Pharma Warning Letters

Here we have a list of Pharma Warning Letters for select pharma manufacturing sites.

Search Select FDA Warning Letters - Updated as of June 15th 2017

Pharmablender.com nor any of its agencies, contractors, subcontractors or employees does not make any warranties, expressed or implied, with respect to data contained in these databases or files, and, furthermore, assume no liability for any partys use, or the results of such use, of any part of the database or files.

FDA Warning Letters From 1-1-2000 to 6-16-2017

Company Subject Issuing Office Letter Issued Closeout Date
Company Subject Issuing Office Letter Issued Closeout Date
A-S Medication Solutions LLC. Failure to Register and List Center for Drug Evaluation and Research
Beacon Prescriptions Compounding Pharmacy/Adulterated Drug Products New Jersey District Office
Belmora LLC Unapproved New Drugs/Misbranded Baltimore District Office
Eugene Airport Interstate Conveyance Sanitation Regulations Seattle District Office
Perfectly Posh New Drug/Labeling/Misbranded Denver District Office
Prestige Brands Holdings Drug Product/Adulterated Center for Drug Evaluation and Research
B. Braun Medical Inc CGMP/Finished Pharmaceuticals/Adulterated Los Angeles District Office
Changzhou Jintan Qianyao Pharmaceutical Raw Materials CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Dougherty's Pharmacy Compounding Pharmacy/Adulteration/Misbranding Dallas District Office
Elkhart Pharmacy Compounding Pharmacy/Adulterated Drug Products Dallas District Office
Genus Medical Technologies Unapproved New Drugs/Misbranded Kansas City District Office
International Medsurg Connection, Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office
Oxford Performance Materials, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office
Pharmaceutic Labs, LLC. Compounding Pharmacy/Adulterated Drug Products New York District Office
Phillips Co. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Rainbow Gold Products Inc Unapproved New Drugs/Misbranded New Orleans District Office
Vertical Pharmaceuticals, Inc Postmarketing Adverse Drug Experience Reporting Requirements New Jersey District Office
Vidco, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
Abbott (St Jude Medical Inc.) CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Center for Devices and Radiological Health
American Specialty Pharmacy Drug Product/Adulterated Dallas District Office
Jus Bar LLC Unapproved New Drugs/Misbranded New York District Office
Mylan Laboratories Limited, (Nashik FDF) CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Professional Arts Pharmacy Drug Product/Adulterated Baltimore District Office
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Ark Bio Medical Canada Corp Premarket Approval/Misbranded/Adulterated Center for Biologics Evaluation and Research
Badrivishal Chemicals & Pharmaceuticals CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Center for Drug Evaluation and Research
Bond Pharmacy, Inc. dba Advanced Infusion Solutions Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New Orleans District Office
Cape Fear Naturals CGMP/Finished Pharmaceuticals/Adulterated Atlanta District Office
Lumis Global Pharmaceuticals Co. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Center for Drug Evaluation and Research
Reliable Rexall-A Compounding Pharmacy Compounding Pharmacy/Adulterated Drug Products San Francisco District Office
Sweet Springs Valley Water Co., Inc. Processing and Bottling of Bottled Drinking Water Regulation/Insanitary Conditions Baltimore District Office
USV Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Dorneyville Pharmacy Compounding Pharmacy/Adulterated Drug Products Philadelphia District Office
Humaworm Unapproved New Drugs/Misbranded New Orleans District Office
Life Extension Foundation Buyers Club, Inc. New Drug/Labeling/Misbranded Florida District Office
Resonance Laboratories Private Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Sato Pharmaceutical Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Cixi Zhixin Bird Clean-Care Product Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Kang Zhang, M.D., Ph.D. Sponsor-Investigator Center for Drug Evaluation and Research
Sato Yakuhin Kogyo Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Suzhou Pharmaceutical Technology Co.,Ltd CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Walter's Pharmacy, Inc. Compounding Pharmacy/Adulteration/Misbranding Philadelphia District Office
Raritan Pharmaceuticals, Inc. CGMP/Manufacturing, Processing, packing, or Holding/Misbranding New Jersey District Office
Soapwalla Inc. New Drug/Labeling Center for Food Safety and Applied Nutrition
Big Dan's Fitness / Nutrition, LLC Internet Marketing of Unapproved and Misbranded Drugs Los Angeles District Office
Empower Clinic Services, LLC Compounding Pharmacy/Adulterated Drug Products Dallas District Office
Herbal Doctor Remedies Unapproved New Drugs/Misbranded Los Angeles District Office
Med-Pharmex, Inc. CGMP/Finished Pharmaceuticals/Adulterated Los Angeles District Office
Sewaren Innovative Pharmaceutical Packaging dba SIPP Drug Product/Adulterated New Jersey District Office
Yusef Manufacturing Laboratories, LLC CGMP/Finished Pharmaceuticals/Adulterated Los Angeles District Office
Adolfo Kaplan Clinical Investigator Center for Drug Evaluation and Research
Aie Pharmaceuticals Inc Unapproved New Drugs/Misbranded Los Angeles District Office
Amazing Sour Sop, Inc. Unapproved New Drugs/Misbranded Florida District Office
BioStar Technology International, LLC Unapproved New Drugs/Misbranded Los Angeles District Office
Caudill Seed & Warehouse Inc Unapproved New Drugs/Misbranded Cincinnati District Office
Criticare Technologies Inc CGMP/QSR/Medical Devices/Adulterated New England District Office
Divi's Laboratories Ltd. (Unit II) CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection Center for Drug Evaluation and Research
DoctorVicks.com Unapproved New Drugs/Misbranded New York District Office
Everything Herbs Unapproved New Drugs/Misbranded Atlanta District Office
Exact-Rx Inc Failure to Register and List Center for Drug Evaluation and Research 2017 - 04
Hawk Dok Natural Salve, LLC Unapproved New Drugs/Misbranded Los Angeles District Office
Healing Within Products & Services, Inc. Unapproved New Drugs/Misbranded San Francisco District Office
Huron Pharmaceuticals, Inc. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Detroit District Office
Lifevantage Corp Unapproved New Drugs/Misbranded Denver District Office
Lonza Walkersville, Inc. CGMP/QSR/Medical Devices/Adulterated Baltimore District Office
Nature's Treasures Unapproved New Drugs/Misbranded Los Angeles District Office
Organ Recovery Systems, Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office
Oxygen Health Systems, LLC Unapproved New Drugs/Misbranded Chicago District Office
Qinhuangdao Zizhu Pharmaceutical, Co. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Sal Pharma CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded Center for Drug Evaluation and Research
Sunstone, Inc. Unapproved New Drugs/Misbranded Denver District Office
The Vitamin C Foundation Unapproved New Drugs/Misbranded Chicago District Office
Tobin's Royal Stag, Inc. dba Tobin Farms Velvet Antler Unapproved New Drugs/Misbranded New England District Office
Unetixs Vascular Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office
Vibrant Health Store, LLC Unapproved New Drugs/Misbranded Seattle District Office
Vikshara Trading & Investments Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Chen Shwezin, Inc. dba Park Compounding Pharmacy Compounding Pharmacy/Adulterated Drug Products Los Angeles District Office
Indoco Remedies Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Merrill D. Benson, M.D. Sponsor/Investigator Center for Drug Evaluation and Research
Opto-Pharm Pte Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Center for Drug Evaluation and Research
Ranier's Compounding Laboratory Compounding Pharmacy/Adulterated Drug Products Philadelphia District Office
South Coast Specialty Compounding, Inc. Compounding Pharmacy/Adulterated Drug Products Los Angeles District Office
Targeted Medical Pharma, Inc. dba Physician Therapeutics Sponsor/Investrigator Center for Drug Evaluation and Research
Trone Health Services, Inc. Compounding Pharmacy/Adulterated Drug Products Seattle District Office
Vacunda & Design New Drug/Misbranded San Juan District Office
Aegeia Skin Care, LLC New Drugs/Cosmetics Labeling and Marketing with Drug Claims Dallas District Office
Chongqing Pharma Research Institute Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Denttio, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Hospira Inc CGMP/Drugs/Adulterated Kansas City District Office
Jinan Jinda Pharmaceutical Chemistry Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Megafine Pharma (P) Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Morton Grove Pharmaceuticals, Inc. CGMP/Finished Pharmaceuticals/Adulterated Chicago District Office
The See Clear Company CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Ausmetics Daily Chemicals (Guangzhou) Co., Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Berkeley Nutritional Mfg Corp. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded San Francisco District Office
Cassandra E. Curtis, M.D. Clinical Investigator Center for Drug Evaluation and Research
CTX Lifesciences Private Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
FACTA Farmaceutici S.p.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Humco Holding Group, Inc CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Porton Biopharma Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Rapid Release Technologies Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Los Angeles District Office
Zhejiang Bangli Medical Products Co., Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Biotronik SE & Co. KG CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy Drug Product/Adulterated Chicago District Office
Enessa Inc New Drugs/Cosmetics Labeling and Marketing with Drug Claims Los Angeles District Office
Harrington House Ltd New Drug/Labeling/Misbranded Center for Food Safety and Applied Nutrition
Hebei Yuxing Bio-Engineering Co Ltd CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
INCYTO CO., LTD. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Mappel Industria de Embalagens S.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Option Care Enterprises, Inc. Compounding Pharmacy/Adulterated Drug Products Seattle District Office
Pacific Healthcare, Inc dba B&B Pharmacy Unapproved New Drug/Compounding/Misbranding/Adulterated Los Angeles District Office
A.R.C.O.S. Srl CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Adamson Analytical Laboratories Inc CGMP/Finished Pharmaceuticals/Adulterated Los Angeles District Office 2017 - 05
Cape Apothecary, Inc. Unapproved New Drug/Compounding/Misbranding/Adulterated Baltimore District Office
Huzhou Aupower Sanitary Commodity CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Jack P. Herick, Inc. dba Glades Drugs Drug Product/Adulterated Florida District Office 2017 - 04
Noven Pharmaceuticals, Inc. CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Plainsboro Pharmacy Compounding Pharmacy/Adulterated/Misbranding New Jersey District Office 2017 - 01
Ropack, Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Savaria Concord Lifts, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Sentara Enterprises CGMP/Finished Pharmaceuticals/Adulterated Baltimore District Office
Spiegelberg Gmbh & Co. KG CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Tata Harper Skincare New Drugs/Cosmetics Labeling and Marketing with Drug Claims New England District Office 2017 - 03
The Wellness Center Pharmacy, Inc., dba Designer Drugs CGMP/Finished Pharmaceuticals/Adulterated/Misbranded New Orleans District Office
Tosoh Bioscience Inc CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Unimark Remedies Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
W & R Investments, LLC CGMP/QSR/Medical Devices/Adulterated New England District Office
Zhejiang Hisoar Pharmaceutical Co. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Brookfield Medical/Surgical Supply, Inc. CGMP/Compounded Drugs/Misbranding New England District Office
GenPak Solutions LLC CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Cincinnati District Office
Health Innovations Pharmacy, Inc CGMP/Compounded Drugs/Misbranding Atlanta District Office
Regional Radiology Mammography Quality Standards New Jersey District Office
86 Harriet Ave Corporation DBA General Devices CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
Austin Biotechnology Inc. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Diabetes Corporation of America Drug Product/Adulterated New Orleans District Office
General Medical Company CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Millers of Wyckoff, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded New Jersey District Office
People's Custom Rx and Clinical Care, LLC CGMP/Compounded Drugs/Misbranding New Orleans District Office
Qualgen Unapproved New Drug/Compounding/Misbranding/Adulterated Dallas District Office
Steroid Bazaar - KABS Software/Nurettin Yagmur Bokurt Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
The Compounding Pharmacy of America CGMP/Compounded Drugs/Misbranding New Orleans District Office
TYRX Inc. CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
Banner Pharmacy Services, LLC CGMP/Compounded Drugs/Misbranding Los Angeles District Office
Economax LLC Unapproved New Drugs/Misbranded New York District Office
F.P. Rubinstein Y Cia SRL CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Master And Frank Ent. Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 02
Renovis Surgical Technologies, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Reviva Labs Inc Unapproved New Drugs/Adulterated New Jersey District Office
Somnowell, Inc. CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
Tai Heng Industry Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research 2017 - 03
Advanced Vision Science Inc CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2016 - 09
Apotheca Supply, Inc CGMP/Active Pharmaceutical Ingredient (API)/Adulterated New Orleans District Office
Florida Institute for Reproductive Sciences and Technologies Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Florida District Office
Oeyama-Moto Cancer Research Foundation IRB Institutional Review Board-IRB Center for Drug Evaluation and Research
Salud Natural Entrepreneurs, Inc. Unapproved New Drugs/Misbranded Chicago District Office
Spot On Sciences, Inc. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health
Sri Krishna Pharmaceuticals Ltd. - Unit II CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
ALV Supplement Direct Unapproved New Drugs/Misbranded Minneapolis District Office
Aussimed Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Cheta Nand, M.D. Clinical Investigator Center for Drug Evaluation and Research
Complete Pharmacy and Medical Solutions LLC CGMP/Compounded Drugs/Misbranding Florida District Office
DMP Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
DrNaturalHealing Inc. New Drug/Misbranded Philadelphia District Office
Emcure Pharmaceuticals Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Essential Pharmacy Compounding CGMP/Compounded Drugs/Adulterated Kansas City District Office
Frontier Cooperative Co CGMP/Medicated Feeds/Adulterated Kansas City District Office
Innovative Sterlization Technologies LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Pikeville Medical Center Inc., Institutional Review Board Institutional Review Board (IRB) Center for Drug Evaluation and Research
SureTek Medical CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Triad Isotopes Inc. CGMP/Compounded Drugs/Adulterated Kansas City District Office
ABC Productions New Drug/Labeling/Misbranded/Cannabidiol Center for Food Safety and Applied Nutrition
Bedfont Scientific, Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2016 - 09
Berwickshire Electronic Manufacturing Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Better Rx, LLC Unapproved New Drugs/Misbranded Dallas District Office
Calwood Nutritionals, LLC. Unapproved New Drugs/Misbranded Baltimore District Office
Dose of Nature New Drug/Labeling/Misbranded/Cannabidiol Center for Food Safety and Applied Nutrition
Eolane Vailhauques CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Fallon Wellness Pharmacy, L.L.C. CGMP/Compounded Drugs/Misbranding New York District Office
Green Garden Gold New Drug/Labeling/Misbranded/Cannabidiol Center for Food Safety and Applied Nutrition
HealthyHempOil.com New Drug/Labeling/Misbranded/Cannabidiol Center for Drug Evaluation and Research
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Michigan Herbal Remedies New Drug/Labeling/Misbranded/Cannabidiol Center for Drug Evaluation and Research
Morguetorium, LLC New Drug/Labeling/Misbranded/Cannabidiol Center for Drug Evaluation and Research
OPS International Incorporated D/B/A Olympia Pharmacy Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Florida District Office
PainBomb New Drug/Labeling/Misbranded/Cannabidiol Center for Drug Evaluation and Research
Sana Te New Drug/Labeling/Misbranded/Cannabidiol Center for Food Safety and Applied Nutrition
Antibioticos Do Brasil Ltda CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Aplicare, Inc. CGMP/Finished Pharmaceuticals/Adulterated New England District Office
Auro Pharmacies, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Los Angeles District Office
Aurora Health and Nutrition Unapproved New Drugs/Misbranded Seattle District Office
Baoying County Fukang Medical Appliance Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Esteem Products LTD Internet Marketing of Unapproved and Misbranded Drugs Seattle District Office
Global Drug Supply Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Healthy Habits New Drugs/Cosmetics Labeling and Marketing with Drug Claims Los Angeles District Office
Horizon Pharmaceuticals, Inc. CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Intega Skin Sciences Inc. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Isomeric Pharmacy Solution, LLC Compounding Pharmacy/Adulterated Drug Products Denver District Office
Natura Bisse International S.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Nomax Inc Medical Devices/Adulterated/Quality System Regulation (QSR) Kansas City District Office
Northern Health Products Unapproved New Drugs/Misbranded Atlanta District Office
Northridge Hospital Medical Cent Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Los Angeles District Office
Pharm D Solutions, LLC Compounding Pharmacy/Adulterated Drug Products Dallas District Office
Pharmco Laboratories Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Florida District Office
Samuel P. Hostetler (DBA) Hump-Back Dairys PHS Act/Unpasteurized Milk For Human Consumption Kansas City District Office
Sincerus Florida, LLC Unapproved New Drugs/Misbranded Florida District Office
Wockhardt, Ltd. CGMP/APIs/Adulterated Center for Drug Evaluation and Research
X2Zero Unapproved New Drugs/Misbranded Dallas District Office
Zyno Medical, LLC CGMP/QSR/Medical Devices/Adulterated New England District Office
BB Riverboats Inc Interstate Conveyance Sanitation Regulations Cincinnati District Office
Bee Products J L Unapproved New Drugs/Misbranded Atlanta District Office
CP Pharmaceuticals CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Dongying Tiandong Pharmaceutical Co Ltd CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Interquim S.A. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Pine Pharmaceuticals, LLC Unapproved New Drug/Compounding/Misbranding/Adulterated New York District Office
Precision Pharmacy Center, LLC Compounding Pharmacy/Adulteration/Misbranding Los Angeles District Office
Prescription Lab Compounding Pharmacy Compounding Pharmacy/Adulteration/Misbranding Los Angeles District Office 2017 - 06
Richard K. Burt Sponsor/Investigator   Center for Biologics Evaluation and Research 2016 - 12
Sekisui Medical Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Srikem Laboratories Pvt. Ltd. CGMP/APIs/Adulterated Center for Drug Evaluation and Research
STI Pharma LLC Postmarketing Adverse Drug Experience Reporting Requirements Philadelphia District Office 2017 - 06
Stonegate Pharmacy LP Compounding Pharmacy/Adulteration/Misbranding Dallas District Office
Thermogram Assessment Services Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health
United Contact Lens, Inc. CGMP/Medical Devices Reporting/Adulterated/Misbranded Seattle District Office
Valeant Pharmacueticals International CGMP/QSR/Medical Devices/Adulterated New York District Office 2017 - 06
Beijing Taiyang Pharmaceutical Industry Co Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Bioque Technology, Inc & Vouray, Inc. Cosmetics/Adulterated Baltimore District Office
BroadMaster Biotech Corp. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Colabs Intl Corp Unapproved New Drugs/Misbranded San Francisco District Office
Diamond Wipes International, Inc. Unapproved New Drugs/Misbranded Los Angeles District Office
Eagle Pharmacy, Inc. Compounding Pharmacy/Adulterated Drug Products New Orleans District Office
Fenwal Inc False & Misleading Claims/Misbranded Center for Biologics Evaluation and Research 2017 - 05
Implant Dental Technology Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
INCELL Corporation LLC Compounding Pharmacy/Adulterated Drug Products Dallas District Office
Interpharm Praha A.S. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
ITW Dymon Drug Product/OTC/Unapproved New Drug Kansas City District Office 2017 - 01
JD & SN Inc., dba Moses Lake Professional Pharmacy Compounding Pharmacy/Unapproved New Drug/Misbranded/Adulterated Seattle District Office
Meditech Laboratories, Inc Drug Product/Adulterated San Francisco District Office
Morton Drug Company dba Morton LTC Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Minneapolis District Office
PhytoCeuticals, Inc. Unapproved New Drugs/Misbranded New Jersey District Office
Pocono Coated Products LLC CGMP/Finished Pharmaceuticals/Adulterated Atlanta District Office
SaveWay Compounding Pharmacy, Inc. Compounding Pharmacy/Adulterated Drug Products Philadelphia District Office
SCS Direct Inc. Unapproved New Drugs/Misbranded New England District Office
Targeted Medical Pharma, Inc. dba Physician Therapeutics Failure to Register and List Center for Drug Evaluation and Research
Teva Pharmaceutical Works Private Limited Company CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Walgreens Infusion Services Drug Product/Adulterated Dallas District Office
Coapt LLC Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Chicago District Office 2017 - 06
DiamoDent CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Isolux, LLC CGMP/QSR/Medical Devices/Adulterated Florida District Office
MasterPharm LLC Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New York District Office
Tibetan Herbal Balance, Inc. Unapproved New Drugs/Misbranded New England District Office
Bellus Medical Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Dallas District Office
Buderer Drug Company Inc Compounding Pharmacy/Adulteration/Misbranding Cincinnati District Office
Cheng Fong Chemical Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Collagen Matrix Inc CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
D&K Foods New Drug/Misbranded Center for Food Safety and Applied Nutrition
Delarange Cosmetics BV CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Desert Farms New Drugs/Cosmetics Labeling and Marketing with Drug Claims Los Angeles District Office
Face Naturals New Drug/Labeling/False & Misleading Claims Center for Food Safety and Applied Nutrition 2016 - 10
Hubei Hongkang Protective Products Co CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Laboratoire Sintyl S.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Navinta, LLC Postmarketing Adverse Drug Experience Reporting Requirements New Jersey District Office
Neo Vision Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Nippon Fine Chemical Co., LTD CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2017 - 03
Osea Internacional New Drug/Labeling/False & Misleading Claims Los Angeles District Office
Positive Power Nutrition New Drug/Misbranded Los Angeles District Office
University Rx Specialties Inc Unapproved New Drug/Compounding/Misbranding/Adulterated Los Angeles District Office
US Specialty Formulations LLC Compounding Pharmacy/Adulterated Drug Products Philadelphia District Office
Wallace Cameron International Ltd Failure to Register and List Center for Drug Evaluation and Research
Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy Compounding Pharmacy/Adulteration/Misbranding Chicago District Office
Yangzhou Hengyuan Daily Chemical Plastic Co Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Amniotic Therapies LLC. CGMP/Deviations/Biologics License Application (BLA) Center for Biologics Evaluation and Research
Brown's Compounding Center, Inc. Unapproved New Drug/Compounding/Misbranding/Adulterated Denver District Office 2016 - 11
Central Admixture Pharmacy Services Inc Unapproved New Drug/Compounding/Misbranding/Adulterated Los Angeles District Office
Central Admixture Pharmacy Services, Inc. Unapproved New Drug/Compounding/Misbranding/Adulterated Philadelphia District Office
College Pharmacy Incorporated CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Denver District Office
Elite Laboratories Inc. Postmarketing Adverse Drug Experience (PADE)   New Jersey District Office
Frontida BioPharm Inc CGMP/Finished Pharmaceuticals/Adulterated Philadelphia District Office 2017 - 04
HMD Biomedical Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Jeffreys Drug Store CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Philadelphia District Office
Lima & Pergher Industria e Comercio S/A CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Medical Specialties of California Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health 2017 - 04
Pan Drugs Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Sarkli Repechage Ltd New Drug/Labeling/Misbranded New Jersey District Office
Shina Corporation CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Simpro CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Southeastern Pharmaceutical Wholesale, Inc. Unapproved New Drug/Compounding/Misbranding/Adulterated New Orleans District Office
The Apothecary Shoppe LLC Unapproved New Drugs/Misbranded Dallas District Office
Xinxiang Tuoxin Biochemical Co. Ltd CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Zo Skin Health Inc. New Drug/Labeling/Misbranded Los Angeles District Office
Ageless Aesthetics New Drug/Labeling/False & Misleading Claims Denver District Office
American Pharmacy of Illinois, Inc. dba Alwan's Pharmacy Drug Product/Adulterated Chicago District Office
Annemarie Gianni Skin Care LLC New Drug/Labeling/Misbranded New England District Office
Beyond Technology Corporation Nanchang CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Celloxess LLC New Drug/Misbranded New Jersey District Office
Concept Products Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Finally Pure, LLC Internet Marketing of Unapproved and Misbranded Drugs Seattle District Office 2017 - 01
Healing Scents New Drug/Labeling/Misbranded Chicago District Office
Hsu's Ginseng Enterprises, Inc New Drug/Labeling/Misbranded Minneapolis District Office 2017 - 06
J&E International Corp Internet Marketing of Unapproved and Misbranded Drugs Seattle District Office
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma Drug Product/Adulterated Chicago District Office
Karen Roche New Drug/Misbranded New England District Office
La Bella Figura New Drugs/Cosmetics Labeling and Marketing with Drug Claims Chicago District Office
Lavian Ltd New Drug/Labeling/Misbranded New York District Office
Menscience Androceuticals New Drug/Labeling/Misbranded Florida District Office
Michael Todd New Drugs/Cosmetics Labeling and Marketing with Drug Claims Florida District Office 2017 - 04
Min Ny New Drug/Labeling/Misbranded New York District Office
Novastep CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Peter Thomas Roth Labs, LLC New Drug/Labeling/Misbranded New York District Office
Right Value Drug Stores, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Sheryl Gibbs New Drug/Labeling/False & Misleading Claims Philadelphia District Office 2016 - 08
Sircuit Skin New Drug/Labeling/False & Misleading Claims Los Angeles District Office 2016 - 09
Techni Med, Inc. dba The Compounder Unapproved New Drugs/Misbranded Chicago District Office
TPR Holding LLC New Drug/Labeling/Misbranded New York District Office
Xiamen Origin Biotech Co. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
American Specialty Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Best Bentonite Unapproved New Drugs/Misbranded Dallas District Office
Centro Naturista Unapproved New Drugs/Misbranded Dallas District Office
Chongqing Lummy Pharmaceutical Co. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Coastal Meds, LLC. CGMP/Compounded Drugs/Misbranding New Orleans District Office
Guangzhou Haishi Biological Technology Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Innovative Compounding Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded San Francisco District Office
John Gabriel, MD Clinical Investigator Center for Drug Evaluation and Research
Mc-Cor, LLC New Drug/Misbranded San Juan District Office 2016 - 11
Oscor, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
S.R. Burzynski Manufacturing Facility CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Shanghai Desano Chemical Pharmaceutical Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research 2017 - 06
SmithKline Beecham Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Trimed Inc CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
BBT Biotech Gmbh CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Bedford Pharmacy Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New England District Office
Corden Pharma Latina S.p.A. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Helica Instruments, Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Hindustan Syringes & Medical Devices Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Horizon Air Industries Inc. Interstate Conveyance Sanitation Regulations Seattle District Office
Jose Giron Clinical Investigator Center for Drug Evaluation and Research
Ko Da Pharmaceutical Co Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Megafine Pharma Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Mooncup LTD CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Orthosoft, Inc. dba Zimmer CAS CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
PCP LV LLC dba Pinnacle Compounding Pharmacy CGMP/Compounded Drugs/Adulterated San Francisco District Office
Qiagen Sciences LLC CGMP/QSR/Medical Devices/Adulterated/Misbranded Baltimore District Office
RXQ Compounding LLC Unapproved New Drug/Compounding/Misbranding/Adulterated Cincinnati District Office
Spectranetics Corporation CGMP/QSR/Medical Devices/Adulterated Denver District Office
Crescent Health Center, Inc Unapproved New Drugs/Misbranded Los Angeles District Office 2016 - 12
Hartley Medical Center Pharmacy, Incorporated CGMP/Compounded Drugs/Misbranding Los Angeles District Office
Hollywood Skincare International Inc. Unapproved New Drugs/Misbranded Florida District Office 2016 - 06
Lincare, Inc. Total Parenteral Nutrition (TPN) Drug Products/Adulterated Dallas District Office
Macular Health New Drug/Misbranded New Orleans District Office 2016 - 10
Neuralight HD, LLC Sponsor/Investigator Center for Drug Evaluation and Research
PharmaLogic CSP, Inc. CGMP/Compounded Drugs/Misbranding Baltimore District Office
Polydrug Laboratories Pvt. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Service First Pharmacies Inc, dba Madison Drugs CGMP/Compounded Drugs/Misbranding New Orleans District Office
Ultimate Weight Loss Co. Unapproved New Drugs/Misbranded Florida District Office
Benedict S. Liao, M.D. Bioresearch Monitoring Program/IRB   Center for Drug Evaluation and Research
Black Onyx World LLC dba Alikay Naturals Unapproved New Drugs/Misbranded Florida District Office
Custom Compounding Center CGMP/Finished Pharmaceuticals/Adulterated Dallas District Office
Eclipse Aesthetics LLC Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Dallas District Office
Gilchrist & Soames Cosmetics/Adulterated Detroit District Office
Grams Medical Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Infusion Options, Inc. CGMP/Compounded Drugs/Adulterated New York District Office
Liberty Drug & Surgical CGMP/Finished Pharmaceuticals/Adulterated New Jersey District Office
Miami Fat Supply, Inc CGMP/QSR/Medical Devices/Adulterated Florida District Office
MRI Imaging Specialist Mammography Quality Standards Atlanta District Office
Oeyama-Moto-Medical Group Foundation, LLC Sponsor/Applicant/Monitor/Contract Research Organization Center for Drug Evaluation and Research
Pharmaceutical Associates Inc Failure to Comply with Drug Listing Requirements Center for Drug Evaluation and Research 2016 - 05
Rx Vitamins, Inc Unapproved New Drugs/Misbranded New York District Office
Terumo Medical Corporation CGMP/QSR/Medical Devices/Adulterated Baltimore District Office
The Wellness Pharmacy LLC CGMP/Finished Pharmaceuticals/Adulterated Baltimore District Office
Winner Aviation Corp Interstate Conveyance Sanitation Regulations Cincinnati District Office
Alexander Neumeister Clinical Investigator Center for Drug Evaluation and Research
C World KSG Corporation CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Chemolee Lab Corporation CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Diversified Pharmacy Inc dba University Compounding Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Detroit District Office
Good Earth Egg Company PHS Act/Shell Egg Regulation/Adulterated Kansas City District Office
Implants International Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Jamaica Hospital Medical Center IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research
Leiter's Compounding Unapproved New Drug/Compounding/Misbranding/Adulterated San Francisco District Office
Lucy's Weight Loss (dba. Waisted With Lucy) Unapproved New Drugs/Misbranded Dallas District Office
Omega Laser Systems CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Repro-Med Systems, Inc. d/b/a RMS Medical Products CGMP/QSR/Medical Devices/Adulterated/Misbranded New York District Office
VitaSea Products Int'l, dba Wachters Organic Sea Products Unapproved New Drugs/Misbranded San Francisco District Office
Gator Feed Company CGMP/Medicated Feeds/Adulterated Florida District Office
Green Supreme Inc. New Drug/Labeling/Misbranded Philadelphia District Office 2016 - 07
Ipca Laboratories Limited CGMP/APIs and Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Kirkman Laboratories, Inc. Unapproved New Drugs/Misbranded Seattle District Office
Physician Preferred Medical, LLC Unapproved New Drugs/Misbranded Dallas District Office
Shenzhen Creative Industry Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Amico Beds Corporation CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Auric Enterprises, Inc. D.B.A. Diack CGMP/QSR/Medical Devices/Adulterated Detroit District Office
Bio-Rad Laboratories GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 07
CMP Industries, Llc CGMP/QSR/Medical Devices/Adulterated New York District Office 2016 - 08
D.O.R.C. Intl. B.V. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health 2016 - 03
Jaychem Industries Ltd CGMP/Finished Pharmaceuticals/Adulterated and Misbranded Center for Drug Evaluation and Research
Ortho Clinical Diagnostics Gmbh CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Pan Drugs Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Richies Produce Inc. Pesticide/Adultered San Juan District Office
Supermercado Econo Inc. E Pesticide/Adultered San Juan District Office
Troy Innovative Instruments Inc CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Van Tibolli Beauty Corp Cosmetics/Adulterated/Misbranded Florida District Office
Vertebral Technologies, Inc. Medical Device Reporting/Misbranded Minneapolis District Office 2017 - 02
APK Technology Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Cardiac Designs Inc. CGMP/QSR/Medical Devices/Adulterated Dallas District Office 2016 - 08
Coram Healthcare Corp. of Indiana Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Detroit District Office
Fujifilm Medical Systems U.S.A., Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Hoya Corporation CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
MWT Materials, Inc. CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
Mylan Laboratories Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Olympus Corporation of the Americas CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Transdermal Cap Inc. CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
HomeopathyStore.com Homeopathic HCG Initiative Center for Biologics Evaluation and Research
KRS Global Biotechnology, Inc Compounding Pharmacy/Adulteration/Misbranding Florida District Office
Lazzaro, Marc, MD Investigational Device Exemptions (Clinical Investigator) Center for Devices and Radiological Health
AG Industries LLC Medical Devices/Adulterated/Quality System Regulation (QSR) Kansas City District Office 2017 - 05
American Lifestyle Unapproved New Drugs/Misbranded New York District Office
CooperSurgical, Inc. Premarket Approval/Misbranded/Adulterated New England District Office 2016 - 04
Country Doctor Herbals Unapproved New Drugs/Misbranded Denver District Office
Green Hills Health and Wellness Pharmacy Inc Unapproved New Drug/Compounding/Misbranding/Adulterated New Orleans District Office
Insulet Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office 2017 - 03
LifeCell Corporation Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health 2017 - 02
Medica Outlet Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
Meds India LTD Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Ondamed GmBH Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
RX Partners Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Thorn Ford Dental Laboratory LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Seattle District Office
Transox Inc CGMP/Finished Pharmaceuticals/Adulterated Atlanta District Office
TriOak Foods Inc CGMP/Medicated Feeds/Adulterated Chicago District Office 2017 - 05
Zhejiang Biomet Medical Products Co. Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 05
Binh Bui-Nguyen, MD Clinical Investigator Center for Drug Evaluation and Research
Dr. Dennis Black Unapproved New Drugs/Misbranded Dallas District Office
KJ3 Inc. Insanitary Conditions/Adulterated Seattle District Office
Pick and Pay Inc dba Cili Minerals Unapproved New Drugs/Misbranded New Orleans District Office
ZYTO Technologies, Inc. Premarket Approval/Misbranded/Adulterated Denver District Office
Applied Medical Resources CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Los Angeles District Office
ARKRAY, Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Battle Creek Equipment Co. CGMP/QSR/Medical Devices/Adulterated Detroit District Office
Better Health Systems, Inc CGMP/QSR/Medical Devices/Adulterated Denver District Office
CXL-USA, LLC Sponsor-Investigator Center for Drug Evaluation and Research
Galena BioPharma Inc Postmarketing Adverse Drug Experience (PADE) Reporting Requirements Seattle District Office
Lac-Mac Limited CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Martech Mdi Inc CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2015 - 11
Medical Components, Inc dba MedComp CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2015 - 10
Natus Medical Incorporated CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded Seattle District Office
Quality Electrodynamics LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office 2016 - 10
Region Care, Inc. Compounding Pharmacy/Adulteration/Misbranding New York District Office
Thermedx LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Visionary Contact Lens dba Visionary CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2017 - 05
Yunnan Hande Bio-Tech. Co. Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Arkray Factory, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Doro, Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Four Elements Organic Herbals, LLC New Drug/Misbranded Minneapolis District Office 2016 - 09
Granja La Cabana PHS Act/Shell Egg Regulation/Adulterated San Juan District Office
Iso-Tex Diagnostics, Inc Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Nanentek Factory CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Taicang Sheng Jia Medical Equipment Science & Technology Co. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Vivek K. Reddy, MD Investigational Device Exemptions (Clinical Investigator) Center for Devices and Radiological Health
Winter Goals CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded Los Angeles District Office
Zizion Group LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Biologics Evaluation and Research
A2Z Industries, LLC Unapproved New Drugs/Misbranded Los Angeles District Office 2016 - 11
Cenorin, LLC Medical Device/Reports of Corrections and Removal/Misbranded/Adulterated Seattle District Office
LCW, INC. Unapproved New Drugs/Misbranded Los Angeles District Office 2015 - 09
Loreal Usa New Drugs/Cosmetics Labeling and Marketing with Drug Claims Center for Food Safety and Applied Nutrition
Moy-Fincher Medical Group Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Perry Drug Inc. Unapproved New Drug/Compounding/Misbranding/Adulterated Kansas City District Office 2016 - 11
Strivectin Operating Company New Drug/Labeling/Misbranded Center for Food Safety and Applied Nutrition 2015 - 06
Verichem Laboratories, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office 2016 - 11
AnazaoHealth Corporation Unapproved New Drug/Compounding/Misbranding/Adulterated San Francisco District Office
ARB Medical, LLC CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
Cadila Healthcare Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Chan Yat Hing Medicine Factory CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Chaya Herbal Food Inc Unapproved New Drugs/Misbranded San Juan District Office
Cosmetic Dermatology Unapproved New Drugs Florida District Office
COTRONIC Technology Limited CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 02
Dherbs Health Emporium Inc. Unapproved New Drugs/Misbranded Los Angeles District Office
Elite Massagers, LLC. CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Episciences Inc New Drugs/Cosmetics Labeling and Marketing with Drug Claims Seattle District Office
Gregory J.Tracey, M.D. Clinical Investigator Center for Drug Evaluation and Research
Ionia Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Los Angeles District Office
Irvine Stem Cell Treatment Center CGMP/Deviations/Biologics License Application (BLA) Center for Biologics Evaluation and Research
LAR MFG., LLC CGMP/QSR/Medical Devices/Adulterated Florida District Office
Miracle in the Green New Drug/Labeling/Misbranded Center for Food Safety and Applied Nutrition
Montana Compounding Pharmacy Compounding Pharmacy/Adulteration/Misbranding Seattle District Office
Moringa Nativa New Drug/Labeling/Misbranded San Juan District Office 2016 - 08
Nature's Health, LLC Unapproved New Drugs/Misbranded Denver District Office
Oculo-Plastik, Inc. CGMP/Finished Pharmaceuticals/Adulterated Center for Devices and Radiological Health
SonicLife.com, LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Seattle District Office
Sorin Group Deutschland GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Spoonamore Drug Co Inc CGMP/Finished Pharmaceuticals/Adulterated Cincinnati District Office
Sun Pharmaceutical Industries Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
TFS Manufacturing Pty Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
The One Minute Miracle Inc New Drug/Labeling/Misbranded Florida District Office
Tri-Med, Inc. dba Advanced Care Infusion-Shelby Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Detroit District Office
Zhejiang Hisun Pharmaceutical Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research 2017 - 06
A1 Engineering CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Advanced Physician Solutions, Inc. CGMP/Finished Pharmaceuticals/Adulterated Los Angeles District Office
Dongguan Jianwei Electronics Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Dr. Reddy's Laboratories Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
E-Care Technology Corp. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Edge Pharmacy Services, LLC CGMP/Finished Pharmaceuticals/Adulterated New England District Office
Heritage Pharmaceuticals, Inc. Postmarketing Adverse Drug Experience (PADE) New Jersey District Office 2016 - 12
Herniamesh S.r.l CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 10
Landmark Aviation PHS Act/Interstate Conveyance Sanitation Atlanta District Office
Linkwin Technology Co Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
McGuff Compounding Pharmacy Services, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Los Angeles District Office
Medisca Inc CGMP/Active Pharmaceutical Ingredient (API)/Adulterated New York District Office 2016 - 05
Monmouth Medical Center IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research
Nature's Mojo Inc Unapproved New Drugs/Misbranded New Jersey District Office
Okamoto Industries, Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 07
Prodimed SAS CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Sagami Rubber Industries Co., Ltd. Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2016 - 05
Shanghai Neo-Medical Import & Export Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Thomas S. Tooma, M.D. Sponsor/Investigator Center for Drug Evaluation and Research
Triangle Compounding CGMP/Finished Pharmaceuticals/Adulterated Atlanta District Office
WalkMed Infusion, LLC CGMP/QSR/Medical Devices/Adulterated Denver District Office 2017 - 05
Xiantao Tongda Non-woven Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
77 Elektronika Kft. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Biomedic Labs, LLC New Drug/Labeling/Misbranded Los Angeles District Office
Cardionics SA CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
CrystalBraces, LLC. CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Digitimer Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Eclipse Aesthetics LLC Premarket Approval/Adulterated Center for Biologics Evaluation and Research 2016 - 01
Fehling Instruments GmbH & Co. KG CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Drug Evaluation and Research
Gentell CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2017 - 03
Hubei Weikang Protective Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Johnson Memorial Cancer Center Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New England District Office
Orgen Nutraceuticals Unapproved New Drugs/Misbranded Detroit District Office
Panoramic Rental Corp. Medical Device Reporting/Misbranded Detroit District Office
Ribon Company, Ltd. Labeling/False & Misleading Claims/Misbranded Center for Food Safety and Applied Nutrition 2016 - 11
Sandoz Private Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Seeds of Light Enterprises Unapproved New Drugs/Misbranded Florida District Office
SSM Health Care St. Louis DBA SSM St. Clare Health Center CGMP/Compounded Drugs/Misbranding Kansas City District Office
Texas Biostetic Instruments CGMP/QSR/Medical Devices/PMA/Adulterated Dallas District Office
Aloe Man, Inc. (The) Unapproved New Drugs/Misbranded Atlanta District Office
Caliber Imaging & Diagnostics, Inc. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health
Collagen Matrix Inc Premarket Approval/Misbranded/Adulterated Center for Devices and Radiological Health
Combo AG CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Conkin Surgical Instruments Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 01
Derma Pen, LLC Premarket Approval/Misbranded/Adulterated Denver District Office
Kaiya Medical (dba Care Medical - Foshan) CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Medical Supply Liquidators Llc New Drug/Labeling/Misbranded Kansas City District Office
Micro Labs Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Praxair Inc. CGMP/QSR/Medical Devices/Adulterated New York District Office 2015 - 09
TreyMed, Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
Argo Medical Technologies Inc. Device/Misbranded Center for Devices and Radiological Health
Aros Surgical Instruments Corporation CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Banyan Medical, LLC CGMP/QSR/Medical Devices/Adulterated New England District Office
Corin Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 02
Ferrosan Medical Devices A/s CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Genesis Biosystems, Inc Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Dallas District Office
GeoTec, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office
Hieber's Pharmacy CGMP/Finished Pharmaceuticals/Adulterated Philadelphia District Office
Hieber's Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Philadelphia District Office
International Medical Development Corporation Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Denver District Office
Life Support Development Ltd Unapproved New Drugs/Misbranded Cincinnati District Office
Lusys Laboratories, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Medsource, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office 2016 - 05
Merge Healthcare, Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office 2016 - 09
Red Mill Farms LLC Unapproved New Drugs/Misbranded Philadelphia District Office
St. Joseph Mercy Oakland Instiutional Review Board Institutional Review Board (IRB)/Investigational Device Exemptions Center for Devices and Radiological Health
St. Jude Medical (CardioMEMS) CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Thai Nippon Rubber Industry Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2016 - 07
Unimark Remedies Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Cellestis Inc CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Civic Center Pharmacy CGMP/Compounded Drugs/Misbranding Los Angeles District Office
Gialive SA de CV Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Global Medical Production Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Guilin Zizhu Latex Co., Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
High Spot Industrial Company, Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
NCS Pearson Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2016 - 07
Rapid Diagnostics, Division Of Mp Biomedicals, Llc Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) San Francisco District Office 2016 - 05
Specialty Medicine Compounding Pharmacy, P.C. Compounding Pharmacy/Adulteration/Misbranding Detroit District Office
Tecres S.p.A. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Ultroid Technologies, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Walgreens Infusion Services CGMP/Finished Pharmaceuticals/Adulterated Dallas District Office
Alphatec Spine, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
American Family Pharmacy, LLC CGMP/Finished Pharmaceuticals/Adulterated Detroit District Office
Beijing KES Biology Technology Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
C.R. Bard, Inc. Premarket Approval/Misbranded/Adulterated Los Angeles District Office 2016 - 12
Cane S.p.A. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Cepheid Ab CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 06
Golden Caviar Skin Care New Drug/Misbranded Center for Food Safety and Applied Nutrition
Lime Crime Cosmetics/Adulterated/Misbranded Center for Food Safety and Applied Nutrition 2015 - 11
Mahendra Chemicals CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Michlin, Bernard A., MD Clinical Investigator Center for Drug Evaluation and Research
One Way Drug, LLC CGMP/Finished Pharmaceuticals/Adulterated/Misbranded San Francisco District Office
Prime Health Products Unapproved New Drug/Misbranding/Adulterated Center for Food Safety and Applied Nutrition
R Thomas Marketing, LLC Unapproved New Drugs/Misbranded New York District Office
Royal Case Co., Inc. CGMP/QSR/Medical Devices/Adulterated Dallas District Office 2016 - 08
Sipra Labs Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Stat Medical Devices, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
AB Science Sponsor/Monitor/Contract Research Organization Center for Drug Evaluation and Research
Attix Pharmaceuticals CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
California Pharmacy & Compounding Center Compounding Pharmacy/Adulteration/Misbranding Los Angeles District Office
Crocker Spinal Technologies Inc Postmarket Surveillance Center for Devices and Radiological Health 2016 - 03
EUROMI S.A. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Gross, Howard M. M.D. Clinical Investigator Center for Drug Evaluation and Research
Innovative Biodefense Inc. Unapproved New Drugs/Misbranded Los Angeles District Office
Jiangsu ZW Pharmaceuticals Co. Ltd. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
MicroPort Orthopedics Inc. Postmarket Surveillance Center for Devices and Radiological Health
SCA Pharmaceuticals Compounding Pharmacy/Adulteration/Misbranding Dallas District Office
Sharon Bio-Medicine Limited Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Syntho Pharmaceuticals, Inc. Generic Drug User Fee Amendments of 2012 (GDUFA)/Failure to Pay Fees Center for Drug Evaluation and Research 2015 - 09
Vista Pharmaceuticals, Ltd. Failure to pay GDUFA Fees Center for Drug Evaluation and Research
Wuxi Kaili Pharmaceutical Company LTD. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Wuxi Kaili Pharmaceutical Company LTD. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
9mm Special Effects CGMP/QSR/Medical Devices/Adulterated/Misbranded San Francisco District Office
Akron Bee Pollen Unapproved New Drugs/Misbranded Cincinnati District Office
Allergen Medical Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health 2016 - 03
CK Management, Inc. Unapproved New Drugs/Misbranded Dallas District Office
Colon Care Products of PA, LLC Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
Dr. Ashley Minas Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
Dr. Hettie Morgan Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
HanChuan FuMo Plastics Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
HHCS Pharmacy, Inc., dba Freedom Pharmacy Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Florida District Office
Insightra Medical Inc CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2015 - 08
Jian Peng Zhou Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
Nephros, Inc. CGMP/QSR/Medical Devices/Adulterated New Jersey District Office 2016 - 04
Pharmagel International New Drug/Labeling/Misbranded Center for Food Safety and Applied Nutrition 2015 - 08
Pharmakon Pharmaceuticals Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Detroit District Office
RICARIMPEX SAS CO. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Spartan Bioscience Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
TEI Biosciences Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
VUAB Pharma a.s. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research 2016 - 03
Absolute Pharmacy, LLC CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Anybattery, Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
Gemdo Cosmetics, Inc. Insanitary Conditions/Adulterated Los Angeles District Office 2016 - 04
Gottfried Medical, Inc. CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
I.V. Specialty, Ltd Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Dallas District Office
Kids Company Ltd Yugengaisha Kids Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health
Leiter's Compounding Unapproved New Drug/Compounding/Misbranding/Adulterated San Francisco District Office
Madison Polymeric Engineering CGMP/QSR/Medical Devices/Adulterated New England District Office
New May King Plastic Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Premier Pharmacy Labs Inc Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Florida District Office
Smith & Nephew, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office 2016 - 12
Soft Computer Consultants, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Stockert GmbH CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 08
Tem Innovations GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 09
Vann Healthcare Services Inc CGMP/Finished Pharmaceuticals/Adulterated Cincinnati District Office
Vibracare Gmbh CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Alexander Infusion LLC D/B/A Avanti Health Care Compounding Pharmacy/Adulteration/Misbranding New York District Office 2017 - 05
Bio Lab-St. Joseph Corp CGMP/QSR/Medical Devices/Adulterated San Juan District Office
Hospira Spa CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2017 - 06
Kings Park Slope Inc Compounding Pharmacy/Adulteration/Misbranding New York District Office
Martin Avenue Pharmacy, Inc. CGMP/Finished Pharmaceuticals/Adulterated Chicago District Office
Rebel Distributors Corp Failure to Register and List Center for Drug Evaluation and Research
RemedyRepack Inc. Failure to Register and List Center for Drug Evaluation and Research 2015 - 05
Skin Authority LLC New Drugs/Cosmetics Labeling and Marketing with Drug Claims Center for Food Safety and Applied Nutrition 2015 - 10
Cadila Pharmaceuticals Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Craftmatic Industries, Inc CGMP/QSR/Medical Devices/Adulterated Florida District Office
Encompas Unlimited, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Flextronics Electronics Technology (Suzhou) Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Hemp Oil Care Unapproved new drug/Misbranded Center for Drug Evaluation and Research
Infiniti Creations Inc Unapproved new drug/Misbranded Center for Drug Evaluation and Research
Inovo, Inc CGMP/QSR/Medical Devices/Adulterated Florida District Office
Modern Herb Shop Unapproved new drug/Misbranded Center for Drug Evaluation and Research
Molteno Ophthalmic Limited Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Multimedical S.R.L. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
MyNicNaxs, Inc. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Florida District Office
Novacyl (Thailand) Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Purecbd.net Unapproved new drug/Misbranded Center for Drug Evaluation and Research
Rodo Medical, Inc. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Center for Devices and Radiological Health
Sopro Comeg Gmbh Premarket Approval/Adulterated Center for Devices and Radiological Health
Tiller MIND BODY, Inc. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Dallas District Office 2016 - 08
XZeal Technologies, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Apotex Research Private Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2016 - 12
Cantrell Drug Company CGMP/Finished Pharmaceuticals/Adulterated Dallas District Office
Carrington Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Chaga Mountain, Inc. Unapproved New Drugs/Misbranded New England District Office 2016 - 09
Criticare Systems (Malaysia) Sdn. Bhd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
F.P. Rubinstein Y Cia SRL CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
GVS Filter Technology UK Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 02
Nanosphere, Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2017 - 06
Oregon Compounding Centers, Inc. dba Creative Compounds CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Seattle District Office
Pristine Nutraceuticals, LLC. New Drug/Labeling/Misbranded Florida District Office
Somatex Medical Technologies GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 11
Aqua, Keith A. M.D. Clinical Investigator Center for Drug Evaluation and Research
John W Hollis Inc Unapproved New Drugs/Misbranded New Orleans District Office
LockDown Medical Ltd. Medical Devices/Adulterated/Quality System Regulation (QSR) Center for Devices and Radiological Health 2015 - 01
MedX Health Corp Medical Devices/Adulterated/Quality System Regulation (QSR) Center for Devices and Radiological Health 2015 - 03
Valeant Pharmaceuticals International CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
221 Enterprises, LLC. Unapproved New Drugs/Misbranded Baltimore District Office
Ad-Med Biotechnology, LLC Unapproved New Drugs/Misbranded Detroit District Office
Brookhurst Mill CGMP/Medicated Feeds/Adulterated/Misbranded Los Angeles District Office 2014 - 12
Carousel Solutions LLC dba Xtract Solutions CGMP/QSR/Medical Devices/Adulterated Seattle District Office
Childrens Medical Ventures CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office
Chromsystems Instruments & Chemicals GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 11
Colgate Oral Pharmaceuticals, Inc. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2014 - 08
Explora Laboratories Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 08
Handsome Industrial (H.K.) Co., LTD CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Korea United Pharm Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2015 - 03
Marel Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office 2015 - 09
Masimo Corporation CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Nidek Inc CGMP/QSR/Medical Devices/Adulterated San Francisco District Office 2015 - 08
o.m.t. Oberflachen - und Materialtechnologie Gmbh CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Spacelabs Healthcare Inc CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
The Compounding Shop, Inc. CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Union Square Medical Imaging & Mammography Mammography Quality Standards New York District Office
Vygon Gmbh & Co. KG CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Wise, John M. M.D. Clinical Investigator Center for Drug Evaluation and Research
Atlantic Trading Co. LLC Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Black International Enterprise, LLC dba Puba Store Unapproved New Drugs/Misbranded Florida District Office
Dr Benedict S Liao Md New Drug/Labeling/False & Misleading Claims Los Angeles District Office
Dr. Bronner's Magic Soaps Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition 2014 - 10
Easy Moon, Inc. - Ramona Egg Ranch PHS Act/Shell Egg Regulation/Adulterated Los Angeles District Office
Infopia Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 09
JCB Labs LLC Compounding Pharmacy/Adulteration/Misbranding Kansas City District Office
Marck Biosciences Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Pharma Tech Solutions, Inc CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Solace International, Inc. Unapproved new drug/Misbranded San Francisco District Office
Trifarma S.p.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 09
Vention Medical CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 02
Ventlab LLC CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2016 - 04
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research 2016 - 07
American Antibiotics, Inc. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2014 - 07
Antibioticos, S.A. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Arno Fritz GmbH CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Carefusion 2200 Inc CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2015 - 09
Enhancement Medical, LLC CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
HeartWare Inc CGMP/QSR/Medical Devices/Adulterated Florida District Office
ID Biomedical Corp., a subsidary of GSK Biologicals CGMP/Deviations/Biologics License Application(BLA) Center for Biologics Evaluation and Research 2015 - 11
Lee and Company CGMP/Finished Pharmaceuticals/Adulterated Dallas District Office
MANI HANOI CO. LTD CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 08
MTI Precision Products LLC. CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
Nutrishop Unapproved new drug/Misbranded New Jersey District Office
Owen Mumford USA, Inc. Medical Device Reporting/Misbranded Atlanta District Office
Smith & Nephew, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Spinal Elements, Inc Premarket Approval/Misbranded/Adulterated Los Angeles District Office
SUZUKEN CO., LTD. OGUCHI CENTER CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 09
Tianjin Zhongan Pharmaceutical Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Advanced Renal Technologies Inc CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office 2016 - 03
Analytical Control Systems, Inc CGMP/QSR/Medical Devices/Adulterated Detroit District Office
Brookfield Prescription Center Inc. dba MD Custom Rx CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Minneapolis District Office 2016 - 01
Dr. Joel Kaplan Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2015 - 05
Grandpa's Compounding Pharmacy, Inc. CGMP/Finished Pharmaceuticals/Adulterated San Francisco District Office
Jade & Pearl, Inc. Medical Device Reporting/Premarket Approval/Misbranded Florida District Office
Led Dental Inc Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health 2015 - 12
Nature's Pharmacy & Compounding Center CGMP/Finished Pharmaceuticals/Adulterated Atlanta District Office
Nuvolase Inc. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device San Francisco District Office
Sun Pharmaceutical Industries Limited - Karkhadi CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Veinwave Ltd Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
American Medical Systems, Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
AMKS TIME RELEASE LAB, LLC Sponsor/Monitor/Contract Research Organization Center for Drug Evaluation and Research
Cytophil, Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office 2014 - 10
Ed Fields & Sons, Inc Pesticide/Adultered Minneapolis District Office 2015 - 01
Graviola Group Unapproved and Misbranded New Drugs San Juan District Office 2015 - 07
LumiQuick Diagnostics Inc. CGMP/QSR/Medical Devices/Adulterated San Francisco District Office 2015 - 10
Sanmina-SCI AB Medical Devices/Adulterated/Quality System Regulation (QSR) Center for Devices and Radiological Health 2014 - 08
SANUM-Kehlbeck GmbH & Co. KG CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Colorado Histo-Prep Good Laboratory Practice (GLP) Center for Drug Evaluation and Research
Deseo Rebajar Unapproved and Misbranded New Drugs San Juan District Office 2015 - 07
Hospira, Inc. CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Jieying Laboratory Inc CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Pentec Health Drug Product/Adulterated Philadelphia District Office
Smruthi Organics Limited CGMP/Finished Pharmaceuticals/Adulterated/HPLC Center for Drug Evaluation and Research
Teleflex Medical CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2015 - 09
Advanced Interventional Pain Ctr IRB Institutional Review Board (IRB) Center for Devices and Radiological Health
Heartsine Technologies Inc Medical Device Reporting (MDR) Regulation Philadelphia District Office 2014 - 10
Swiss Mountain View Egg Farm PHS Act/Shell Egg Regulation/Adulterated Los Angeles District Office
USV Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Customed, Inc CGMP/QSR/Medical Devices/Adulterated San Juan District Office 2016 - 12
Degania Medical Devices Pvt Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 03
Delta Pharma, Inc. CGMP/Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New Orleans District Office
Karl Storz Endovision, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded New England District Office
Maquet Cardiopulmonary Ag Premarket Approval/Misbranded/Adulterated Center for Devices and Radiological Health 2016 - 04
MicroAire Surgical Instruments, LLC CGMP/QSR/Medical Devices/Adulterated Baltimore District Office 2016 - 06
Moor Instruments Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Novacyl Wuxi Pharmaceutical Co., Ltd. CGMP/Finished Pharmaceuticals/Active Pharmaceutical Ingredient(API)/Adulterated Center for Drug Evaluation and Research
Nuga Medical Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Oxysure Systems, Inc. CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Padtest, LLC Medical Device Reporting/Misbranded Los Angeles District Office 2016 - 01
Quality Liquid Feeds, Inc CGMP/Medicated Feeds/Adulterated Minneapolis District Office 2015 - 08
Reka Health Pte Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Sagemax Bioceramics, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
Saint Mary's Medical Group, Inc. Mammography Quality Standards San Francisco District Office
Shanghai Hua Yue Packaging Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Shoreside Enterprises Inc. Unapproved New Drugs/Misbranded Florida District Office
Signal Medical Corporation Premarket Approval/Adulterated Detroit District Office
Vinyas Innovative Technologies Pvt., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Wakai, Ronald, Ph. D. Investigational Device Exemptions (Clinical Investigator) Center for Devices and Radiological Health
Biotest Pharmaceuticals Corp. CGMP/Deviations/Biologics License Application (BLA) Office of Regulatory Affairs
Bodyhealth.com, LLC Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Cell Vitals New Drug/Labeling/Misbranded Center for Food Safety and Applied Nutrition 2015 - 04
Ebola-C Inc Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
EMcision Ltd. Medical Devices/Adulterated/Quality System Regulation (QSR) Center for Devices and Radiological Health 2015 - 09
Eurotrol B. V. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 03
Excelsior Medical Corp CGMP/QSR/Medical Devices/Adulterated New Jersey District Office 2020 - 12
Fioravanti Custom Products DBA Essential Wholesale & Labs New Drugs/Cosmetics Labeling and Marketing with Drug Claims Seattle District Office
Jansen Enterprises, LLC dba HealthWorksUSA New Drug/Labeling/Misbranded Minneapolis District Office
LifeSilver Unapproved New Drugs/Misbranded Center for Food Safety and Applied Nutrition
Navilyst Medical, Inc. CGMP/QSR/Medical Devices/Adulterated New York District Office 2015 - 11
Nemschoff Chairs, Inc. Medical Device Reporting/Misbranded Minneapolis District Office 2016 - 09
New Hope Fertility Center Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) New York District Office 2016 - 07
Remington Medical, S.A. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Respironics California Inc Medical Device Reporting/Misbranded Los Angeles District Office
Shantou Chaonan Liangying Hegao Plastic Toy Factory CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 10
Sixdog Investments, LLC PHS Act/Shell Egg Regulation/Adulterated Denver District Office
Stanmore Implants Worldwide Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Taewoong Medical Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 09
Topspins, Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2017 - 01
U S Infusion, Inc. dba Truecare Biomedix-USA CGMP/QSR/Medical Devices/Adulterated Florida District Office 2015 - 11
Voss Plastics, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Dallas District Office
Wells Pharmacy Network LLC CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Alpha Medical Instruments, LLC CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Bethel Nutritional Consulting, Inc New Drug/Misbranded New York District Office
Biomerieux Inc CGMP/QSR/Medical Devices/Adulterated Kansas City District Office 2015 - 09
Citrus Fit Unapproved New Drugs/Misbranded Dallas District Office
DIMA S.L. Medical Devices/Adulterated/Quality System Regulation (QSR) Center for Devices and Radiological Health 2016 - 04
Dongguan Jianwei Electronics Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Eastern Pharmacy, Inc. Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Florida District Office 2016 - 08
Electronic Development Labs, Inc Medical Device Reporting/Misbranded Baltimore District Office 2015 - 06
Golden Pride, Inc. Unapproved New Drugs/Misbranded Florida District Office
Health Research Laboratories LLC New Drug/Misbranded Dallas District Office
Health Research Laboratories LLC New Drug/Misbranded Dallas District Office
Hikma Farmaceutica, (Portugal) S.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 11
Kawada Sanitary Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
PerkinElmer Health Sciences, Inc. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device Center for Devices and Radiological Health 2017 - 01
Pharmagen Laboratories, Inc CGMP/Finished Pharmaceuticals/Adulterated New England District Office
PI Pharma Inc Unapproved New Drugs/Misbranded Cincinnati District Office
RX South DBA RX3 Compounding Pharmacy LLC CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Baltimore District Office
Sekisui Medical Co., Ltd CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 12
Sharp Global Limited CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Failure to Register Center for Drug Evaluation and Research 2017 - 02
Taber, Louise A., MD Clinical Investigator Center for Drug Evaluation and Research
Vitamins Direct (USA), Inc. Unapproved New Drugs/Misbranded Florida District Office
Western/Scott Fetzer Company CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Xanacare Technologies, LLC CGMP/QSR/Medical Devices/Adulterated Denver District Office
YoungYou International Inc Unapproved New Drugs/Misbranded Los Angeles District Office 2015 - 04
Zhejiang Tiansong Medical Instrument Co., Ltd CGMP/QSR/Medical Devices/PMA/Adulterated Center for Devices and Radiological Health
Zhongshan Mei Tung Electronics Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 10
Jeff Mlsna PHS Act/Shell Egg Regulation/Adulterated Minneapolis District Office 2015 - 01
Mega Electronics Ltd. Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2015 - 10
Mercy Hospital Medical Center IRB Institutional Review Board (IRB) Center for Devices and Radiological Health
Obstetrics Gynecology, Ltd Mammography Quality Standards Dallas District Office
AGFA Healthcare Corp. CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Ambco Electronics, A California Corp CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2015 - 07
ArjoHuntleigh Inc. Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)/Adulterated Dallas District Office 2015 - 07
Beacon Hill Medical Pharmacy, P.C. Unapproved New Drugs/Misbranded Detroit District Office
Beijing Shunxin Meihua Bio-technical Co., Ltd. Limited Inspection/Refused Inspection/Adulterated Center for Drug Evaluation and Research
Calcomp Nutrition Llc Unapproved New Drugs/Misbranded Philadelphia District Office 2015 - 10
China Resources Sanjiu Medical and Pharmaceutical Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Failure to Register/Unapproved or Misbranded Center for Drug Evaluation and Research
Cook Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office
doTERRA International, LLC Unapproved New Drugs/Misbranded Denver District Office
Express Diagnostics Int'l., Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
Hospira Australia Pty Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2016 - 02
Laser Engineering, Inc. CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
Laserworld Usa Inc Electronic Product Radiation Control Center for Devices and Radiological Health
Mayfair Medical Supplies Ltd Medical Devices/Adulterated/Quality System Regulation (QSR) Center for Devices and Radiological Health 2015 - 10
Middle East Bakery, Inc. Labeling/False & Misleading Claims/Misbranded New England District Office
Multimmunity, Inc. New Drug/Labeling/Misbranded Denver District Office
Natural Solutions Foundation Unapproved New Drugs/Misbranded New Jersey District Office
Nova Products, Inc. Unapproved New Drugs/Misbranded Philadelphia District Office 2015 - 01
Powers Device Technologies Inc Premarket Approval/Misbranded/Adulterated Florida District Office
West Coast Laboratories Inc Unapproved New Drugs/Misbranded Los Angeles District Office 2015 - 04
Young Living Unapproved New Drugs/Misbranded Denver District Office
Zoll Lifecor Corporation CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2015 - 10
Andapharm, LLC Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2014 - 10
Brava, LLC Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
CreAgri, Inc. New Drug/Labeling/False & Misleading Claims San Francisco District Office
Descor LLC Unapproved New Drugs/Misbranded Baltimore District Office
Elite Massagers, LLC CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Fleming Laboratories Ltd. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2017 - 01
Health Science Products Inc CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
HUMAN SCIENCE FOUNDATION Unapproved Drugs/Misbranded Los Angeles District Office
Iradimed Corporation CGMP/QSR/Medical Devices/Adulterated Florida District Office
Laboratorios Senosiain SA de CV Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2015 - 03
Marck Biosciences Ltd. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Meridian Co., Ltd. Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Microtest Laboratories, Inc. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2014 - 09
OrgSyn Laboratory Inc Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Pacific Vision Institute Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Simply Clean Air & Water Inc. CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated New England District Office 2015 - 11
Zions Rx Formulations Services LLC dba Rx Formuations Serv. CGMP/Finished Pharmaceuticals/Adulterated Los Angeles District Office
Abrams Royal Pharmacy Compounding Pharmacy/Adulteration/Misbranding Dallas District Office 2016 - 09
Alzohalli, Opada M.D. Clinical Investigator Center for Drug Evaluation and Research
AMS Health Sciences Unapproved New Drugs/Misbranded Dallas District Office 2016 - 04
Baxter Healthcare SA/dba Baxter Healthcare of Puerto Rico CGMP/QSR/Medical Devices/Adulterated San Juan District Office 2015 - 10
Bioland Technology Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Borinquen Natural, Inc. New Drug/Misbranded San Juan District Office
C P Health Products Inc. CGMP/Finished Pharmaceuticals/Adulterated New York District Office
Calaire Chimie S.A.S. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Contract Coating, Inc. Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research
Healthtime dba Deer Garden Foods New Drug/Labeling/Misbranded San Francisco District Office
Julian Bakery, Inc. False & Misleading Claims/Misbranded Los Angeles District Office 2015 - 02
Klein Laboratories, Inc. Unapproved New Drug/Adulterated New England District Office
M.D. Science Lab CGMP/Finished Pharmaceuticals/Adulterated Florida District Office 2016 - 08
Medinol Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 02
Med-Mizer, Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office
MKL DIAGNOSTICS AB CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
PharMEDium Services, LLC Compounded Drugs/CGMP Chicago District Office
Plexus Worldwide Inc New Drug/Misbranded Los Angeles District Office
Protech Professional Products, Inc. Premarket Approval/Adulterated Florida District Office
RC Compounding Services, LLC Insanitary Conditions/Adulterated Cincinnati District Office
Repromed Fertility Center Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Dallas District Office
Schindele Enterprises dba Midwest Wholesale Unapproved/Misbranded drugs Kansas City District Office
Syfrett Feed Co. CGMP/Medicated Feeds/Adulterated Florida District Office
Tianjin New Bay Bioresearch Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Weiner, Gilbert R. Clinical Investigator Center for Drug Evaluation and Research
Advanced MicroVas II, LLC CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Apotex Pharmachem India Pvt Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2016 - 12
Clinical Specialties Compounding Pharmacy Drug/Prepared, Packed or Held Under Insanitary Conditions/Adulterated Atlanta District Office
CNMC Company, Inc. CGMP/QSR/Medical Devices/PMA/Adulterated New Orleans District Office 2015 - 07
Conductive Technologies, Inc CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2015 - 08
Corporacion Avicola Morovis Inc PHS Act/Shell Egg Regulation/Adulterated San Juan District Office
Dexta Corporation CGMP/QSR/Medical Devices/Adulterated San Francisco District Office
I.T.S. GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Pharmacy Creations CGMP/Finished Pharmaceuticals/Adulterated New Jersey District Office
Phillips Respironics, Inc. CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2015 - 03
Ramon Rosa Unapproved new drug/Misbranded San Juan District Office 2015 - 07
Unomedical s.r.o. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 07
Zarbee's, Inc. New Drug/Labeling/Misbranded Denver District Office
Zynex Medical, Inc. CGMP/QSR/Medical Devices/Adulterated Denver District Office
A.R.C. LASER GMBH Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Aesthetics Systems Usa Inc Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Cardiac Assist, Inc Medical Device Reporting/Misbranded Philadelphia District Office 2014 - 11
Hemcon Medical Technologies, Inc. Device/Lacks Premarket Approval Notification/Adulterated Seattle District Office
Life Force of Tampa, LLC CGMP/QSR/Medical Devices/Adulterated Florida District Office
Neurolumen LLC CGMP/QSR/Medical Devices/Adulterated Dallas District Office 2015 - 11
Oakdell Pharmacy, Inc CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Precision Needle Manufacturing, Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
R&D Engineering Of Earlham Inc Medical Device/CGMP/Adulterated Kansas City District Office
Staar Surgical Co. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Steris Isomedix Services CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2015 - 11
The Utopia Group LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Acme Monaco Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office 2014 - 11
Americare Compounding, LLC. CGMP/Finished Pharmaceuticals/Adulterated New York District Office 2017 - 02
Birhiray, Ruemu Clinical Investigator Center for Drug Evaluation and Research
Blue Ridge Pharmacy and Compounding Center CGMP/Finished Pharmaceuticals/Adulterated Atlanta District Office 2016 - 06
Charlemagnes Tree Farm Ltd dba Hudson Valley Homestead Labeling/Misbranded New York District Office
Cook Vascular Inc. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Fandino, Ana J. Clinical Investigator Center for Drug Evaluation and Research
Galanz Microwave Oven and Electrical Appliances Manufacturing Co. Ltd. Medical Devices/Winchester Engineering and Analytical Center (WEAC) Center for Devices and Radiological Health
GaleMed Xiamen Co., Ltd. Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2014 - 08
Gold Standard Diagnostics Quality System Regulation for Medical Devices/Adulterated San Francisco District Office 2015 - 04
Greer Laboratories Inc CGMP Deviations  Office of Regulatory Affairs
Instituto Bioclon, S.A. de C.V. CGMP Deviations Center for Biologics Evaluation and Research 2015 - 08
Iowa Select Herbs New Drug/Labeling/Misbranded/CGMP/Adulterated Kansas City District Office
Ip-6 International Inc. Unapproved and Misbranded New Drugs Florida District Office
Labotech Microscopes India Private Limited Medical Device Reporting/Adulterated/Misbranding Center for Devices and Radiological Health 2016 - 07
Mar Cor Purification CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office 2015 - 03
Mundo Natural Inc Unapproved and Misbranded New Drugs San Juan District Office 2014 - 11
River Hills Harvest dba Elderberrylife Labeling/False & Misleading/New Drug/Misbranded Kansas City District Office 2015 - 12
Rogerio Lobo, M.D. Sponsor Center for Drug Evaluation and Research
Sewell, Michele M.D. Clinical Investigator Center for Drug Evaluation and Research
All American Coop CGMP/Medicated Feeds/Adulterated Minneapolis District Office 2015 - 01
Atom Medical Corporation CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Dexcom Inc Medical Device Reporting Regulation/Misbranded Los Angeles District Office 2015 - 05
Impladent Ltd. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health 2016 - 01
Instrumed Gmbh Medical Device Reporting/Adulterated/Misbranding Center for Devices and Radiological Health 2015 - 07
Jonathan S. Allgyer PHS Act/Shell Egg Regulation/Adulterated Minneapolis District Office 2015 - 01
Kaiser Air Inc PHS Act/Interstate Conveyance Sanitation San Francisco District Office
M&A Caribbean Traders, Inc Unapproved and Misbranded New Drugs San Juan District Office 2014 - 05
Moussa C. Mansour, MD Clinical Investigator - Human Trials Center for Devices and Radiological Health 2016 - 03
Pattanam D. Srinivasan, MD Sponsor-Investigator Center for Devices and Radiological Health
Prismatik Dentalcraft, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Los Angeles District Office
Sandeep Bagla, MD Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Center for Devices and Radiological Health
Shima Laboratories Co., Ltd. CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Center for Devices and Radiological Health 2017 - 04
SmithKline Beecham (Cork) Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 08
Ultradent Products, Inc. CGMP/QSR/Medical Devices/Adulterated Denver District Office 2014 - 11
Canton Laboratories Pvt. Ltd. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Cooper Vision Caribbean Corp. CGMP/QSR/Medical Devices/Adulterated San Juan District Office 2014 - 10
Lowlite Investments, Inc. D/B/A Olympia Pharmacy CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Neomedix Corp Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2014 - 05
Newberry Feed & Farm, Inc. CGMP/Medicated Feeds/Adulterated Atlanta District Office
Nora Apothecary Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Detroit District Office
Pallimed Solutions, Inc. CGMP/Drugs/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New England District Office
Richard Wolf Medical Instruments Corp. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2015 - 06
Total Pharmacy Services, Inc. CGMP/Finished Pharmaceuticals/Adulterated New Orleans District Office
Village Fertility Pharmacy, Inc. CGMP/Drugs/Prepared, Packed or Held Under Insanitary Conditions/Adulterated New England District Office 2016 - 07
Wedgewood Village Pharmacy, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded New Jersey District Office
Zimmermann, Ralf C. Clinical Investigator Center for Drug Evaluation and Research
Advanced Magnetic Research Institute International LLC Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Advanced Photonic Systems, LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Amgen, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2015 - 01
Avella of Deer Valley, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Los Angeles District Office 2017 - 02
Back To Back Medical, LLC CGMP/QSR/Medical Devices/Adulterated Florida District Office
Baxter Healthcare Corp. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2017 - 02
C.S.O. S.R.L. Medical Device Reporting/Adulterated/Misbranding Center for Devices and Radiological Health 2014 - 08
CBSCHEM LIMITED CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
China Daheng Group Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2014 - 07
ConMed Electrosurgery CGMP/QSR/Medical Devices/Adulterated Denver District Office 2016 - 08
Cotton High Tech S.L. (d/ba COHITECH) Quality System Regulation for Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2016 - 03
Exclusive Supplements, Inc. Unapproved and Misbranded New Drugs Philadelphia District Office 2015 - 12
Home Intensive Care Pharmacy, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office 2014 - 02
Hudson Radiology Center Mammography Quality Standards New Jersey District Office
Insert Depot, Inc CGMP/QSR/Medical Devices/Adulterated Florida District Office
Lucky Beauty Equipment Co., LTD. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k); Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Medaus, Inc. CGMP/Finished Pharmaceuticals/Adulterated New Orleans District Office
Pacific Standard Distributors, inc Internet Marketing of Unapproved and Misbranded Drugs Seattle District Office
Recsei Laboratories, LLC Unapproved and Misbranded New Drugs Los Angeles District Office
Slim Beauty USA Unapproved New/Misbranded drugs Kansas City District Office
Stanton Brothers PHS Act/Shell Egg Regulation/Adulterated Kansas City District Office
Triangle Compounding New Drug/Misbranded Atlanta District Office
Agila Specialties Private Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Nassim, Omid M.D. Clinical Investigator Center for Drug Evaluation and Research
Neuro Kinetics, Inc. Premarket Approval/Misbranded/Adulterated Philadelphia District Office 2015 - 12
Sirakoff, Dimitri Clinical Investigator Center for Drug Evaluation and Research
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 03
Virginia Center for Reproductive Medicine Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Baltimore District Office
Conair Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office 2015 - 03
Deroyal Cientifica De Latinoamerica S.R.L. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2015 - 05
Electro Medical, Inc CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Hair Labs International, Inc. CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
Healing Dives, Inc. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Herbal Papaya New Drug/Labeling/Misbranded Dallas District Office
Hubei Weikang Protective Products Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Huestis Machine Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office 2014 - 05
Hyperbaric Options Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
LifeServe Blood Center CGMP Blood & Blood Components/Adulterated Kansas City District Office 2014 - 07
Ontex Hygieneneartikel Gmbh Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Oxyhealth, LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2014 - 04
Posh Chemicals Private Limited CGMP/Finished Pharmaceuticals/Adulterated/HPLC Center for Drug Evaluation and Research
Pressure Tech Inc Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2014 - 04
Promed Exports Private Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
St Joseph Mercy Oakland IRB Institutional Review Board (IRB) Center for Devices and Radiological Health
The Reynolds Office of Health and Nutrition Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2014 - 04
Vibrant Life New Drug/Labeling/Misbranded Los Angeles District Office 2014 - 03
Zeppessis Reprocessing, LLC CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
Cispharma Inc. CGMP/Finished Pharmaceuticals/Adulterated New Jersey District Office
Enraf-Nonius B.V. Adulterated Device Center for Devices and Radiological Health
Fresenius Kabi Oncology Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Health King Enterprise & Balanceuticals Group, Inc. Unapproved new drug/Misbranded Chicago District Office 2014 - 06
Meridian Medical Systems LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
NINGBO LINGGUANG ELECTRIC APPLIANCE CO., LTD. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
SCM True Air Technologies LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Alma Lasers, Inc. Medical Device Reporting/Misbranded Chicago District Office 2014 - 01
Asahi Kasai Medical Co., Ltd. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2014 - 04
Automated Ophthalmics, Inc. CGMP/QSR/Medical Devices/Adulterated Baltimore District Office 2014 - 02
Changzhou Qianhong Bio-Pharma Co., Ltd Failure to Register and List Center for Drug Evaluation and Research 2013 - 07
Doft, Bernard H. M.D. Clinical Investigator Center for Drug Evaluation and Research
Frazer, Henry A. Pharm D Clinical Investigator Center for Drug Evaluation and Research
Genesis BPS, LLC. Premarket Approval/Misbranded/Adulterated New Jersey District Office 2016 - 03
GS Medical Packaging Inc Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
MEDINVENTS NV Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2014 - 12
Penn Pharmaceuticals Services Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 10
San Diego Cold Storage Insanitary Conditions/Adulterated Dallas District Office
Techlem Medical Corporation Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
TYTEX SLOVAKIA S.R.O. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2014 - 07
Ace Medical Corp., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Alternative Health Supplements Unapproved and Misbranded New Drugs Detroit District Office
Apnea Sciences Inc CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Los Angeles District Office
Boehringer Ingelheim Pharma GMBH & Co CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2014 - 06
Earthborn Products, Inc. New Drug/Labeling/Misbranded Los Angeles District Office
Entrenet Nutritionals, Inc. Unapproved and Misbranded New Drugs Philadelphia District Office 2014 - 12
GRI Medical & Electronic Technology Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2014 - 10
Hospira Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2016 - 10
Invatec S.p.A. Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2015 - 02
Kronner Prototypes, Inc Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Seattle District Office
LISA Laser Products OHG Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2015 - 04
Riverpoint Medical, LLC CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
Rubimed AG CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
SmartPractice False & Misleading Claims/Misbranded Center for Biologics Evaluation and Research
Standard Textile Co Inc Premarket Approval/Misbranded/Adulterated Cincinnati District Office 2013 - 06
Superex Canada Ltd Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
The Standing Company CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2015 - 11
Valley Health/Winchester Medical Center IRB Institutional Review Board (IRB) Center for Devices and Radiological Health 2015 - 07
WEBER MEDICAL GMBH Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Alveologic LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Baxter Healthcare Corporation Quality System Regulation for Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Body Systems Inc. Unapproved and Misbranded New Drugs Florida District Office
CORPAK MedSystems, Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2014 - 12
Excel Medical Products, Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office
Juve International, LLC New Drug/Labeling/False & Misleading Claims Denver District Office
Kanebo Cosmetics Inc. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Musculoskeletal Transplant Foundation Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) New Jersey District Office 2015 - 03
Natures Health Options LLC Unapproved and Misbranded New Drugs Florida District Office
Oy Ajat Ltd Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Realm Labs, LLC Unapproved and Misbranded New Drugs Florida District Office
Spine Smith Holdings, LLC CGMP/QSR/Medical Devices/Adulterated Dallas District Office 2015 - 09
Algaen Corporation Unapproved New Drug/Adulterated/Misbranded Atlanta District Office
Continental Medical Labs, Inc. CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Minneapolis District Office 2013 - 11
Cynergy, LLC / Dermaroller Gmbh Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Fisioline s.r.l. Quality System Regulation/Medical Device Reporting/Adulterated Center for Devices and Radiological Health
Fresenius Medical Care, North America CGMP/QSR/Medical Devices/Adulterated Denver District Office 2015 - 04
Linet Spol. S.r.o. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2013 - 05
Lodato Gennaro & C S.p.A. Labeling/False & Misleading Claims/Misbranded Center for Food Safety and Applied Nutrition
Medi-Fare Drug and Home Health Center CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Atlanta District Office
Nanhai Meishida Beauty Equipment Co., LTD Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Natural Medicine Associates, Inc Unapproved and Misbranded New Drugs Florida District Office
NuVasive Inc Premarket Approval/Misbranded/Adulterated Los Angeles District Office 2014 - 03
Revecomed International Inc Premarket Approval/Adulterated Los Angeles District Office
Shatila Food Products, Inc. Labeling/False & Misleading Claims/Misbranded Detroit District Office
Stryker Instruments Div. of Stryker Corporation CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2014 - 01
VE Valley Electronics GmbH Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2014 - 01
Arizona Hydroponic Farming, LLC CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Los Angeles District Office 2013 - 10
Big Mountain Drugs Unapproved New Drud/Misbranded Center for Drug Evaluation and Research
buy-pharma.com Unapproved new drug/Misbranded Center for Drug Evaluation and Research
CMS Imaging, Inc., Electronic Product Radiation Control Atlanta District Office 2014 - 11
Discount Online Pharmacy Unapproved Products Related to the 2012/2013 Flu Season Center for Drug Evaluation and Research
Futrex Incorporated Premarket Approval/Adulterated Baltimore District Office 2013 - 07
Kosher Vitamin Express Unapproved Products Related to the 2012/2013 Flu Season Center for Food Safety and Applied Nutrition
Medsnoscript Unapproved Products Related to the 2012/2013 Flu Season Center for Drug Evaluation and Research
Medsys s.a. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health
Oasis Consumer Healthcare, LLC Unapproved Products Related to the 2012/2013 Flu Season Center for Drug Evaluation and Research
Secure Medical Inc Unapproved Products Related to the 2012/2013 Flu Season Center for Drug Evaluation and Research
Singing River Hospital System IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research
Sun Drug Store Unapproved Products Related to the 2012/2013 Flu Season Center for Drug Evaluation and Research
Supplementality LLC Unapproved Products Related to the 2012/2013 Flu Season Center for Food Safety and Applied Nutrition 2013 - 08
Tan Extreme Inc Premarket Approval Application (PMA) Chicago District Office
University of Berkley Unapproved Products Related to the 2012/2013 Flu Season Center for Biologics Evaluation and Research
Vitalmax Vitamins Unapproved Products Related to the 2012/2013 Flu Season Center for Food Safety and Applied Nutrition
Ameriderm Laboratories, Ltd. CGMP/Finished Pharmaceuticals/Adulterated New Jersey District Office
Amplion Clinical Communications Inc CGMP/QSR/Medical Devices/Adulterated New Orleans District Office 2014 - 06
Baxter Healthcare Corporation CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2017 - 05
Burzynski Research Institute Sponsor/Monitor/Contract Research Organization Center for Drug Evaluation and Research
Burzynski, Stanislaw R. MD Clinical Investigator Center for Drug Evaluation and Research
Coastal Contacts Inc. Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2015 - 07
DNA Genotek Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Florida Fertility Institute Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Florida District Office 2014 - 08
Green Planet Inc Unapproved and Misbranded New Drugs Los Angeles District Office 2014 - 11
Hubbard Feeds, Inc. CGMP/Medicated Feeds/Adulterated Detroit District Office 2015 - 01
Mapa Gmbh Medical Device Reporting/Adulterated/Misbranding Center for Devices and Radiological Health 2015 - 04
Market Technologies Inc. DBA Dermavista Medical Device Reporting/Misbranded New Orleans District Office
Philips Healthcare Medical Device Reporting/Misbranded Los Angeles District Office
Racer Technology Pte Ltd Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 07
Rehabtronics Inc. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
SKINREX CO., LTD Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Star Scientific, Inc. Unapproved and Misbranded New Drugs, Anatabloc and CigRx Center for Food Safety and Applied Nutrition 2014 - 10
Subcon Manufacturing Corporation Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Chicago District Office 2014 - 05
23andMe, Inc. Premarket Approval/Adulterated Center for Devices and Radiological Health 2014 - 03
Ad-Tech Medical Instrument Corporation CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office 2014 - 10
Agnes E. Ubani, MD Clinical Investigator   Center for Drug Evaluation and Research
Cheen Houng Enterprise Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 07
Clinical Lasers, Inc. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
David C. Kauffman PHS Act/Shell Egg Regulation/Adulterated Kansas City District Office
Hyperion Medical Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Jubilant HollisterStier, LLC CGMP/Finished Pharmaceuticals/Adulterated Seattle District Office
Kootenai Medical Center IRB Institutional Review Board (IRB) Center for Devices and Radiological Health
Manhattan Reproductive Medicine, PC Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) New York District Office
Mectra Labs, Inc. Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Samudrala, Sreedhar Clinical Investigator Center for Drug Evaluation and Research
San Up S.A. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health
Sharplight Technologies CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Center for Devices and Radiological Health
Shoney Scientific India Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
St Vincent Hosp And Hlth Care Institutional Review Board (IRB) Center for Drug Evaluation and Research
SYNECCO LTD. CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Center for Devices and Radiological Health 2015 - 04
Trokamed GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 05
Velmahos, George C. M.D., Ph.D Clinical Investigator - Human Trials Center for Biologics Evaluation and Research 2014 - 01
Wockhardt Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Allergy Laboratories, Inc. CGMP Deviations  Office of Regulatory Affairs
Aptalis Pharma Us Inc CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
Avacen Inc Premarket Approval/Misbranded/Adulterated Los Angeles District Office
R82 A/S Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
RZM Food Factory Insanitary Conditions/Adulterated San Francisco District Office
Virtual Sun, LLC CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
A C Cossor & Son (Surgical) Limited Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Aionex Inc CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated New Orleans District Office 2014 - 08
Canon USA Inc Medical Device Reporting/Misbranded Los Angeles District Office 2013 - 10
Curatronic Ltd. Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
GUANGDONG BIOLIGHT MEDITECH CO., LTD CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 02
Interojo Inc. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2013 - 12
Lightwave Technologies, LLC Premarket Approval/Misbranded/Adulterated Los Angeles District Office
Physicians Total Care, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Richway NF Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health
St Jude Medical CRMD CGMP/QSR/Adulterated/Misbranded Los Angeles District Office 2014 - 06
Usine Rotec Inc Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Wexford Labs Inc Device/CGMP/QSR Kansas City District Office 2015 - 05
American Aesthetics Medical Supply, Inc. Medical Device Reporting/Misbranded Dallas District Office
ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Batrik Medical Mfg., Inc. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
C.P.M. Contract Pharma GmbH & Co. KG Generic Drug User Fee Amendments of 2012 (GDUFA) Center for Drug Evaluation and Research 2014 - 01
Capillus LLC CGMP/QSR/Medical Devices/Adulterated Florida District Office
Dennis J. Hurwitz, M.D. Clinical Investigator - Human Trials Center for Devices and Radiological Health
Dolgencorp Inc Labeling/False & Misleading Claims/Misbranded New Orleans District Office
Epflex Feinwerktechnik GmbH Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 07
Fomar Import/Export Inc. Insanitary Conditions/Adulterated Dallas District Office
General Hearing Instruments Inc CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
Globus Medical, Inc. CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2014 - 03
Haciendas Morales dba Granja Avicola Morales PHS Act/Shell Egg Regulation/Adulterated San Juan District Office
Homeolab Inc. Labeling/False & Misleading Claims/Misbranded Center for Drug Evaluation and Research
Insight Pharmaceuticals Corporation Labeling/False & Misleading Claims/Misbranded Philadelphia District Office 2014 - 09
King Systems Corp. CGMP/QSR/Medical Devices/Adulterated Detroit District Office
Medical Device Resource Corp CGMP/QSR/Medical Devices/Adulterated San Francisco District Office
Medtech Products, Inc. Labeling/False & Misleading Claims/Misbranded New York District Office 2014 - 11
Medtronic MiniMed Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health 2014 - 12
Nephron Pharmaceuticals Corp. New Drug/Misbranded Florida District Office
NIDEK Co., Ltd., Hamacho Plant Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2017 - 05
Standard Homeopathic Company, Inc. False & Misleading Claims/Misbranded Los Angeles District Office
Suzhou Armocon Technology Co. Ltd Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 11
Topco Assoc Labeling/False & Misleading Claims/Misbranded Chicago District Office
Bio Focus Co. Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 12
Dako Denmark A/S Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 04
Dolphin Intertrade Corporation Unapproved and Misbranded New Drugs Florida District Office
Fenwal, a Fresenius-Kaby Company CGMP/Finished Pharmaceuticals/Adulterated San Juan District Office 2014 - 04
FVS Holdings, Inc. dba. Green Valley Drugs New Drug/Misbranded San Francisco District Office
GumRunner, LLC New Drug/Labeling/False & Misleading Claims Center for Food Safety and Applied Nutrition
Jabones Pardo S.A. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research
Sanquin Plasma Products CGMP Deviations Center for Biologics Evaluation and Research 2016 - 09
Soleetech Corporation Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
St. Shine Optical Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Stewart Compounding Pharmacy CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Atlanta District Office
The Centre for Reproductive Medicine Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Dallas District Office
Ulrich GmbH & Co. KG Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Vision RT Ltd Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Willow Farms PHS Act/Shell Egg Regulation/Adulterated New Orleans District Office
Aarti Drugs Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Amrutam Life Care Pvt. Ltd. Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Anastasia Marie Laboratories, Inc. Unapproved new drug/Misbranded Dallas District Office
Axium Healthcare Pharmacy dba Balanced Solutions Compounding New Drug/Labeling/Adulterated/Misbranded Florida District Office
CHUNGDO PHARM. CO. LTD. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Enhance Nutraceutical Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Farmer John Egg Enterprises, Inc. PHS Act/Shell Egg Regulation/Adulterated San Francisco District Office
Glytain Unapproved new drug/Misbranded Florida District Office
Health Care Products Unapproved new drug/Misbranded New York District Office
INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max Unapproved New Drugs/Misbranded Center for Drug Evaluation and Research
Intuitive Surgical, Inc. CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded San Francisco District Office 2014 - 04
LumiQuick Diagnostics Inc. Premarket Approval/Adulterated San Francisco District Office 2015 - 10
Magni Co Unapproved new drug/Misbranded Dallas District Office
Nature Cast Products Unapproved new drug/Misbranded Florida District Office
Nature's Health Supply Unapproved new drug/Misbranded Los Angeles District Office 2014 - 02
Neuliven Health Unapproved new drug/Misbranded Los Angeles District Office
Northern Digital Inc. Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2015 - 11
Origin BioMed Inc. Labeling/False & Misleading Claims/Misbranded Center for Drug Evaluation and Research
Peter Schiff Enterprises Quality System Regulation for Medical Devices/Adulterated New Orleans District Office
Pharmaterra, Inc. Unapproved new drug/Misbranded Seattle District Office
Wockhardt Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Wonjin Mulsan Co., Ltd. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
www.tob-one.com Unapproved new drug/Misbranded Center for Drug Evaluation and Research
Alpha Medical Instruments, LLC Investigational Device Exemptions(IDE)/Premarket Approval Application (PMA) Los Angeles District Office
Andi International Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Biomedix, Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office
EvaPharmacy Internet Marketing of Unapproved and Misbranded Drugs Center for Drug Evaluation and Research
Formulife, Inc. Unapproved New Drug/Adulterated/Misbranded Dallas District Office
Graftys, S.A. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2014 - 03
Huvepharma Inc Medicated Feed/Adulterated Kansas City District Office
Janet K Tillisch, MD Clinical Investigator-Human Trials   Center for Biologics Evaluation and Research 2013 - 07
KooJoo Trading Company Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Lucky Board Manufacturing Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
North Dallas Honey Labeling/New Drug/Misbranded Dallas District Office
Nutrient Synergy, Inc New Drug/Labeling/Misbranded Denver District Office
Transonic Systems Inc Quality System Regulation for Medical Devices/Adulterated New York District Office 2014 - 01
Baxter Healthcare Corporation CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated Atlanta District Office
Bio-Botanica, Inc. New Drug/Misbranded New York District Office
Contract Pharmaceutical Services of Australia Pty Ltd CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
ConvaTec Inc. CGMP/QSR/Medical Devices/Adulterated New Jersey District Office 2016 - 02
Crop Pharms Unapproved and Misbranded New Drugs New York District Office
Custom Compounding Centers, LLC Unapproved and Misbranded New Drugs Los Angeles District Office 2015 - 12
Ebewe Pharma Ges MBH Nfg KG CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 09
Edwards Lifesciences, LLC CGMP/QSR/Medical Device Reporting/Adulterated Denver District Office 2016 - 07
Gexfix SA CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 01
Hospira Healthcare India Pvt. Ltd. CGMP/Adulterated Center for Drug Evaluation and Research
Joseph-Vempilly, Jose, MD Clinical Investigator Center for Drug Evaluation and Research
K S Choi Corp CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Los Angeles District Office
Kerber, Inc. Labeling/False & Misleading Claims/Misbranded Philadelphia District Office 2013 - 12
Matrix Health Products Internet Marketing of Unapproved and Misbranded Drugs Seattle District Office
Medys S.p.A. Adulterated Device Center for Devices and Radiological Health
Ortho-Cycle Company Inc. CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Florida District Office
RPG Life Sciences Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Shen Clinic, LLC. New Drug/Misbranded San Francisco District Office 2013 - 11
So-Low Environmental Equipment Co. Inc. CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
SpineNet CGMP/QSR/Medical Devices/Adulterated Florida District Office
Zi Xiu Tang Success, LLC Unapproved and Misbranded New Drugs Philadelphia District Office 2013 - 12
ACell, Inc CGMP/QSR/Medical Devices/Adulterated Baltimore District Office 2016 - 06
Aurora Optics Company Inc Medical Device Reporting/Misbranded New York District Office
Biocompatibles Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office 2014 - 04
Care Diagnostica GmbH Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
CMI Cosmetic Manufacturers Inc. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
CooperSurgical, Inc. D.B.A. Lone Star Medical Products CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Dallas District Office
Electromedical Products International, Inc CGMP/QSR/Medical Devices/Adulterated Dallas District Office 2014 - 09
Europharma Co., Inc. New Drug/Labeling/False & Misleading Claims Minneapolis District Office
Glottal Enterprises Inc. Medical Device Reporting/Misbranded New York District Office 2015 - 03
Glucorell, Inc. / Anafit, Inc. Unapproved and Misbranded New Drugs Florida District Office
MEDICAMAT S.A. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2014 - 08
Natus Europe GmbH Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2014 - 01
Nouritress Hair Products, LLC CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Olympia Womens Health Deviations from CFR Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Seattle District Office
Puget Sound Blood Center and Program CGMPs for Blood & Blood Products/Finished Pharmaceuticals/Adulterated Seattle District Office
Shippert Medical Technologies CGMP/QSR/Medical Devices/Adulterated Denver District Office 2014 - 08
V-SAB Medical Labs, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Atlanta District Office
Acclarent, Inc. Medical Device Reporting/Misbranded San Francisco District Office 2014 - 01
Agnesian Healthcare IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research
Alexion Pharmaceuticals, Inc. CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated New England District Office
Asada Milling Co., Ltd. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Center for Drug Evaluation and Research
Birkdale Medicinals LLC Unapproved and Misbranded New Drugs Detroit District Office 2014 - 03
Body, Mind & Soul, Inc. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Eiken Chemical Co., Ltd. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2014 - 09
Feel Tech Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Foremost Foods International, Inc./Seafood City Labeling/False & Misleading Claims/Misbranded Los Angeles District Office
Innovative Med Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2014 - 02
KayPENTAX, A Division of PENTAX Medical Company CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
Keystone Laboratories Inc CGMP/Finished Pharmaceuticals/Adulterated/Misbranded New Orleans District Office
Mega Sun Inc CGMP for Medical Device/QSR/Adulterated Kansas City District Office
Peking Medicine Manufactory CGMP/Finished Pharmaceuticals/Unapproved/Misbranded Center for Drug Evaluation and Research
Safecross First Aid Ltd Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health
Synticare Corp New Drug/Labeling/False & Misleading Claims Los Angeles District Office
THD SpA Quality System Regulation/Medical Device Reporting/Adulterated Center for Devices and Radiological Health
Wyeth Lederle S.p.A CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Abbey Color, Inc. CGMP/Active Pharmaceutical Ingredient (API)/Adulterated Philadelphia District Office
Altasource LLC DBA Metalabs LLC Unapproved and Misbranded New Drugs Atlanta District Office
Amresco LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Apotex Inc CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research 2014 - 05
Atossa Genetics, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
Boyd Mahrt and Ingrid Mahrt PHS Act/Shell Egg Regulation/Adulterated San Francisco District Office
CoRE Labs, LLC Medical Device Reporting/Misbranded Denver District Office 2014 - 12
GRANTECH CO., LTD. Quality System Regulation/Medical Device Reporting/Adulterated Center for Devices and Radiological Health
Integra Neurosciences PR, Inc. CGMP/QSR/Medical Devices/Adulterated San Juan District Office 2015 - 01
Interlab S.r.l. Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 05
Jubilant HollisterStier General Partnership CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2014 - 09
Kral X-ray Inc. Electronic Product Radiation Control Atlanta District Office
Laclede Inc CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Los Angeles District Office
Prodigy Diabetes Care, LLC Medical Device Reporting/Misbranded Atlanta District Office 2014 - 04
TOADS LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
ASI Medical, Inc. Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health 2013 - 04
Bacterin International, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office
Bacterin International, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office 2013 - 09
CFS Dental, Inc CGMP/QSR/Medical Devices/Adulterated Florida District Office
CryoLife, Inc. CGMP/QSR/Medical Devices/Adulterated Atlanta District Office 2015 - 04
Flu & Cold Defense LLC Unapproved Products Related to the 2012/2013 Flu Season Center for Drug Evaluation and Research
FSSB Chirurgische Nadeln Gmbh Quality System Regulation/Medical Device Reporting/Adulterated Center for Devices and Radiological Health 2015 - 08
Michael Ring, MD Clinical Investigator - Human Trials Center for Devices and Radiological Health 2015 - 01
P.A. Benjamin Manufacturing Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research
Pinsky Mark, MD Clinical Investigator - Human Trials Center for Devices and Radiological Health
Pishon Trading Inc Medical Device Reporting/Misbranded Los Angeles District Office 2013 - 05
Sovereign Pharmaceuticals, LLC CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Dallas District Office
Spes Medica Srl Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Tecval Medical Sarl Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Woo Young Medical Medical Devices/Adulterated/Quality System Regulation(QSR) Center for Devices and Radiological Health 2015 - 01
C.C. & Son Farms, Incorporated PHS Act/Violation/Adulterated San Francisco District Office
DMC Medical Technology & Manufacturing Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
EPS Biotechnology Corp. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2013 - 10
Fercy Personal Care Products Co., Ltd CGMP/Finished Pharmaceuticals/Adulterated & Failure to Register and List Center for Drug Evaluation and Research
Greek Island Labs New Drug Application [NDA] Center for Food Safety and Applied Nutrition
Gyrus ACMI, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office
Hyphen BioMed Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 10
John Joseph Hewett, M.D. Clinical Investigator - Human Trials Center for Devices and Radiological Health
Lancome New Drug Application [NDA] Center for Food Safety and Applied Nutrition 2012 - 11
Mir-Com Products LLC CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2013 - 03
Noble Anesthesia-Air, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Petaluma Farms PHS Act/Shell Egg Regulation/Adulterated San Francisco District Office
Quzhou Chemsyn Pharm Co Ltd Failure to Register and List  Center for Drug Evaluation and Research
Synergy Health Concepts, Inc Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Unisis Corporation CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Analyticon Biotechnologies AG CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Asept Pak Inc. Device/Adulterated New York District Office
Boukhari Prince Medical BPM sa CGMP for Medical Devices/QSR/Adulterated/Misbranded Center for Devices and Radiological Health
Compumedics Germany Gmbh CGMP/QSR/Medical Devices/Misbranded Center for Devices and Radiological Health 2017 - 02
Henrys Farm Inc. Insanitary Conditions/Adulterated Baltimore District Office
HSAC Enterprises, Inc. dba Kare-N-Herbs Drug/Labeling/False & Misleading Claims New England District Office 2012 - 09
Kimberly-Clark Corporation Devices/Misbranded Atlanta District Office
Prince Medical CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
SpineFrontier, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office 2013 - 09
Sure On Industries Ltd. Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2014 - 10
Alfa Vitamins Laboratories, Inc. New Drug/Labeling/False & Misleading Claims Florida District Office
Center for the Improvement of Human Functioning International, Inc. IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research
Cutera Inc. Device/Adulterated Center for Devices and Radiological Health
Franck's Lab Inc., d.b.a. Franck's Compounding Lab Labeling/False & Misleading Claims/Misbranded/Adulterated/Insanitary Conditions Florida District Office
Leisegang Feinmechanik-Optik GmbH CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2016 - 05
NeuroTherm, Inc. CGMP/QSR/Medical Devices/Adulterated New England District Office
Quantum Devices, Inc. Device/Adulterated Center for Devices and Radiological Health
Sanofi Pasteur CGMP Deviations Center for Biologics Evaluation and Research 2014 - 04
Advocate Health Care Institutional Review Board (IRB) Center for Drug Evaluation and Research 2014 - 04
Bausch & Lomb ELC SPL Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
Beekley Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office 2015 - 06
CardioMEMS, Inc. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Endogastric Solutions, Inc. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
F Care Systems USA Medical Device Reporting/Misbranded/Adulterated Florida District Office
Fenwal, a Fresenius-Kaby Company False & Misleading Claims/Misbranded Center for Biologics Evaluation and Research 2013 - 05
lnnovision A/S CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2014 - 02
Michigan Medical Innovations CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2013 - 06
Nevyas Eye Associates Misbranding Center for Devices and Radiological Health
Oertel Medical GmbH Adulterated Device Center for Devices and Radiological Health
Our Lady of Bellefonte Hospital Institutional Review Board (IRB) Center for Drug Evaluation and Research
Set-N-Me-Free Aloe Vera Co. New Drug/Labeling/False & Misleading Claims/Misbranded Seattle District Office
Zhucheng Haotian Pharm Co., Ltd. Failure to Register and List Center for Drug Evaluation and Research
Acorda Therapeutics Inc. Adverse Drug Experience (ADE) New York District Office
Amplivox Ltd CGMP for Medical Devices/QSR/Adulterated Center for Devices and Radiological Health
Andersen Sterilizers Inc Premarket Approval/Misbranded Atlanta District Office
B.M.P. Pharma Trading AG CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Belmont Instrument Corporation Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
BTS S.p.A. Device/Adulterated Center for Devices and Radiological Health 2012 - 09
CareFusion Corp dba Productos Urologos De Mexico S.A. De C.V. Device/Adulterated Center for Devices and Radiological Health 2012 - 07
Human Biosciences, Inc. Premarket Approval/Misbranded Baltimore District Office 2013 - 08
Inova Health Care Services, Inova Blood Donor Services CGMP Regulation for Blood and Blood Products/Adulterated Baltimore District Office 2012 - 11
Mediagnost GmbH CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Millar Instruments, Inc. Device/Adulterated Dallas District Office 2013 - 07
Quadex Pharmaceuticals, LLC OTC Drug Labeling/New Drug/Misbranded Denver District Office 2012 - 06
Siemens Healthcare Diagnostics, Inc CGMP/QSR/Medical Devices/Adulterated New England District Office 2013 - 05
Stingray Surgical Products, LLC CGMP/QSR/Medical Devices/Adulterated Florida District Office
Terumo Medical Products Hangzhou Co., Ltd. Adulterated Device Center for Devices and Radiological Health 2013 - 06
ThermaSolutions Incorporated Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
United Medical Center Mammography Quality Standards Baltimore District Office
Ad-Tech Medical Instrument Corporation CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Minneapolis District Office 2014 - 10
Healing With Essiac Tea False & Misleading Claims/New Drug Florida District Office
K-Brand Farms PHS Act/Shell Egg Regulation/Adulterated New York District Office 2012 - 07
LasikPlus Vision Center Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Leaner Living Unapproved New Drug Promotional Claims/Misbranded Baltimore District Office
Myotronics-Noromed Inc. Medical Device Lacks Premarket approval/Misbranded Seattle District Office 2012 - 08
NovaLung Gmbh CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2013 - 08
Octapharma USA, Inc. Promotional Claims/Misbranded Center for Biologics Evaluation and Research 2012 - 11
Peking Medicine Manufactory Failure to Register and List Center for Drug Evaluation and Research
TZ Medical Inc. Medical Device Reporting/Misbranded Seattle District Office
Upspring, Ltd Medical Device/Adulterated/Misbranded Center for Devices and Radiological Health
Breathable Foods, Inc. False & Misleading Claims/Misbranded New England District Office
Cosmed S.R.L. CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Farma Quimia S.A. de C.V. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Heartway Medical Products Co., Ltd. CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated Center for Devices and Radiological Health 2015 - 07
Hill-Rom, Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2015 - 09
Laboratorios Jaloma S.A. de C.V. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2014 - 07
Nobilus Ent CGMP for Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 06
Osypka Medical GmbH CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Pax-All Manufacturing Inc. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 04
SystemsOne, LLC CGMP for Medical Devices/QSR/Adulterated/Misbranded Florida District Office
Warner Chilcott Company, LLC CGMP Regulations for Finished Pharmaceuticals/Adulterated San Juan District Office 2013 - 06
Advanced Surgical Design & Manufacture, Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Home Care Technologies USA, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Los Angeles District Office 2012 - 10
I.E.M. GmbH Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Intelligent Hospital Systems Adulterated Device Center for Devices and Radiological Health 2013 - 06
Orthopedic Alliance CGMP/QSR/Adulterated/Misbranded Los Angeles District Office
Probed Medical Technologies, Inc. Adulterated Device Center for Devices and Radiological Health 2012 - 08
West-Ward Pharmaceuticals Corp. CGMP for Finished Pharmaceuticals/Adulterated New Jersey District Office 2014 - 03
20/20 Institute, Indianapolis Lasik Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Alcon LenSx, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office 2014 - 05
Axiobionics CGMP/QSR/Medical Devices/Adulterated Detroit District Office
Barton-Carey Products, Inc. CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
Beanne Chemical Co. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Central Surgical Co. Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Contract Medical International Spol. S.o.r. Medical Device Reporting Regulation/Adulterated/Misbranded Center for Devices and Radiological Health
Energist Limited CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 01
Eye Center of Texas Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Hameln Pharmaceuticals Gmbh CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2015 - 02
Hangzhou Jinlin Medical Appliances Co., Ltd. Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health 2013 - 05
Lifewatch Services, Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2016 - 09
Midwest Poultry Services LP PHS Act/Shell Egg Regulation/Adulterated Cincinnati District Office
Novo Nordisk A/S CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2014 - 01
Port of Cascade Locks Interstate Conveyance Sanitation Regulations Seattle District Office 2013 - 05
Prime Herbs Corporation CGMP for Medical Devices/QSR/Adulterated/Misbranded San Francisco District Office
Rand Eye Institute Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
ScottHyver Visioncare, Inc Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
SKS Enterprises, Inc., dba Honen Ranch 1-4 PHS Act/Shell Egg Regulation/Adulterated San Francisco District Office
Sunbeam Products, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Taiwan Three Mast Pharmaceutical Co.Ltd. CGMP/Finished Pharmaceuticals/Misbranded Center for Drug Evaluation and Research
The Judge Rotenberg Educational Center Device/Adulterated New England District Office
Tianjin Hanaco Xingda Medical Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
TMS International Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Warren Farms LLP PHS Act/Shell Egg Regulation/Adulterated New Orleans District Office 2014 - 09
Woolfson Eye Institute Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
A & D Electronics (Shenzhen) Co., Ltd. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health 2013 - 08
Ansar Group, Inc. d/b/a Ansar Medical Technologies, Inc CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office
CASMED International, Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Dzebovskaya, Yelena d/b/a Matrix Health Line Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Emu Products and Management, Inc. (EPMI) New Drug/Misbranded Dallas District Office
GC America, Inc. Device/Adulterated Chicago District Office
InControl Medical, LLC CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office 2014 - 01
Integra NeuroSciences Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 06
Laser Energetics, Inc. Electronic Product Radiation Control Center for Devices and Radiological Health
Leisure Products, Inc. Device/Adulterated New Orleans District Office
Medart A/S Medical Device Reporting Regulation/Misbranded Center for Devices and Radiological Health
Mi Gwang Contact Lens Co., Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 09
Mindray DS USA, Inc. d.b.a. Mindray North America CGMP/QSR/Medical Devices/Adulterated New Jersey District Office
oBand Centers Westwood, CA Promotion and Advertising/Misleading/Misbranded Center for Devices and Radiological Health
Osachi Co. Ltd. CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 11
Parks Medical Electronics, Inc. CGMP/QSR/Medical Devices/Adulterated Seattle District Office
Phoenix Instruments, Inc. CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2013 - 07
Rigid FX Orthopedics, Inc CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Salem Hospital IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research 2014 - 04
Shanghai Huhui Daily Use Chemical Products Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research
SHANGHAI RUIKE SPORTS GOODS CO., LTD. Quality System Regulation/Medical Device Reporting/Adulterated Center for Devices and Radiological Health
Solta Medical, Inc. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Sometech Incorporated Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
The Avalon Effect Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Tissue Bank International/The National Eye Bank Center Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products(HCT/Ps) New Orleans District Office
Tonica Elektronik A/S Quality System Regulation for Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Trillium Farms LLC PHS Act/Shell Egg Regulation/Adulterated Cincinnati District Office
Women's Health Institute of Texas New Drug/Misbranded Dallas District Office 2013 - 11
Akorn, Inc. New Drug/Misbranded Chicago District Office 2014 - 10
Alere San Diego, Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Atrium Medical Corporation CGMP/QSR/Medical Devices/Adulterated New England District Office
Avon Products, Inc. (U.S. Headquarters) New Drug/Misbranded Center for Food Safety and Applied Nutrition
Balin, Martin S., MD, PhD Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Chicago District Office 2013 - 04
Bausch & Lomb, Inc. New Drug/Misbranded Florida District Office
Bioque Technology New Drug Application [NDA] Center for Food Safety and Applied Nutrition
Country Fresh Orlando, LLC Labeling/False & Misleading Claims/Misbranded Florida District Office 2013 - 07
DMX-Works, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office 2013 - 07
Finca Cojobas, Inc. PHS Act/Shell Egg Regulation/Adulterated San Juan District Office
Garlic Rx New Drug/Labeling/Misbranded Cincinnati District Office
Global Medical Holdings LLC CGMP/QSR/Medical Devices/Adulterated Kansas City District Office
Health Breakthroughs International, LLC Internet Marketing of Unapproved and Misbranded Drugs Seattle District Office
Hiossen Inc. CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2013 - 11
I Shay Cosmetics Inc CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Los Angeles District Office
International Laboratories (Canada) Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research
MEDDEV USA, INC. Medical Devices/Adulterated/Quality System Regulation (QSR) Dallas District Office
Medical Device Resource Corp Premarket Approval/Misbranded/Adulterated San Francisco District Office
Mushroom Wisdom, Inc. Unapproved and Misbranded New Drugs New Jersey District Office
NeuroMed Devices, Inc. Quality System Regulation for Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Nexera Medical, Inc. CGMP/QSR/Medical Devices/Adulterated Florida District Office
Nissei Precision Instruments (Suzhou) Co., Ltd CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Ortho Molecular Products Inc New Drug/Labeling/Misbranded Minneapolis District Office 2014 - 12
PC Tan Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
PerioSeal, Inc. CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Primus Medical LLC CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Cincinnati District Office
Quanta Systems, S.p.A. Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Quincy Bioscience Manufacturing Inc. Unapproved and Misbranded New Drugs Minneapolis District Office
RTI Biologics, Inc. Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) Florida District Office 2013 - 10
Skin Biology, Inc. New Drug/Labeling/False & Misleading Claims Seattle District Office
SMT-Schilling Metalltechnik GmbH CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health 2015 - 07
Stat Rx USA CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Atlanta District Office
Sugih Instrumendo Abadi, PT. Quality System Regulation for Medical Devices/Adulterated Center for Devices and Radiological Health
Tri State Agri Services, LLC CGMP for Licensed Medicated Feeds/Adulterated Dallas District Office
Westone Laboratories Incorporated CGMP/QSR/Medical Devices/Adulterated Denver District Office 2013 - 09
William C. Domb, D.M.D., A Professional Corporation CGMP/QSR/Medical Devices/Adulterated/Misbranded Los Angeles District Office
Xiantao Rayxin Medical Products Co. Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Zian Medical, LLC Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Advanced Orthogonal Equipment, Inc. QSR/Medical Devices/Adulterated Florida District Office
Agora Publishing Inc New Drug/Labeling/Misbranded Baltimore District Office
Augusta Medical Systems, LLC CGMP/QSR/Medical Devices/Adulterated Atlanta District Office
Health Science Products Inc Medical Device Reporting/Misbranded New Orleans District Office
Herbal Extracts Plus, LLC New Drug/Labeling/Misbranded Philadelphia District Office 2012 - 08
Medical Quant USA Premarket Approval/Adulterated Cincinnati District Office 2012 - 11
Norland, A Cooper Surgical Company CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded Minneapolis District Office 2012 - 09
Orthotics & Prosthetics One Inc CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Kansas City District Office 2015 - 01
Progressive Medical Inc CGMP/QSR/Medical Devices/Adulterated/Misbranded Kansas City District Office 2012 - 08
Soring Medical Technology Medical Device Reporting/Misbranded Florida District Office
Thoratec Corporation CGMP/QSR/Medical Device Reporting/Misbranded San Francisco District Office
Acu International Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Andes Natural New Drug Application [NDA] Center for Food Safety and Applied Nutrition
Arkadiy Kisin/White Forest Solutions Unapproved and Misbranded New Drugs Center for Drug Evaluation and Research
Boyce, Steven W., M. D. Clinical Investigator Center for Drug Evaluation and Research
Canadadrugs Unapproved and Misbranded New Drugs Center for Drug Evaluation and Research
Celltex Therapeutics Corporation Human Cells, Tissues & Cellular Products Center for Biologics Evaluation and Research
Copious International, Inc Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2013 - 04
EMG Manufacturing Co., Ltd. CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Epimed International, Inc. CGMP/QSR/Medical Devices/Adulterated New York District Office
EyeScience Labs, L.L.C. Promotional Claims False & Misleading/New Drugs Cincinnati District Office
First Medical Source LLC CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Healthy People CO Unapproved and Misbranded New Drugs Los Angeles District Office
Hospital Bella Vista Mammography Quality Standards San Juan District Office
Janson-Beckett New Drug Application [NDA] Center for Food Safety and Applied Nutrition
Kaiser Permanente - 20th Avenue Medical Center Mammography Quality Standards Dallas District Office
Lime Essentials Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) Center for Devices and Radiological Health
Memorial Hospital Of South Bend, IRB Institutional Review Board (IRB) Center for Drug Evaluation and Research 2014 - 04
Oregon Aesthetic Technologies, Inc. CGMP/QSR/Medical Devices/Adulterated Seattle District Office
Pronet/Eyal Bar Oz Unapproved and Misbranded New Drugs Center for Drug Evaluation and Research
Pulse Health LLC CGMP/QSR/Medical Devices/Adulterated/Misbranded Seattle District Office 2013 - 04
Southwind Foods LLC dba Great American Seafood Imports Co. Labeling/Misbranded Los Angeles District Office
Texas Applied Biomedical Services Institutional Review Board (IRB) Center for Biologics Evaluation and Research
Zimmer Manufacturing B.V. CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation San Juan District Office
Aino Co., Ltd. of North China Pharmaceutical Group Failure to Register and List Center for Drug Evaluation and Research 2012 - 12
BioMerieux, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Atlanta District Office
Blends Maker Mfg Inc. HACCP/Adulterated San Juan District Office
Centrum Valley Farms, LLP (South Complex) PHS Act/Shell Egg Regulation/Adulterated Kansas City District Office 2014 - 07
DPT Lakewood, LLC CGMP/Finished Pharmaceuticals/Adulterated/Misbranded New Jersey District Office 2013 - 02
Dragon Herbs New Drug/Labeling/False & Misleading Claims Los Angeles District Office
EEG Info Device/Adulterated/Misbranded Los Angeles District Office 2013 - 04
Farmers Coop Co CGMP/Medicated Feeds/Adulterated Kansas City District Office 2013 - 03
Generic Medical Devices, Inc. CGMP/QSR/Medical Devices/Adulterated Seattle District Office
Healing Ways New Drug/Labeling/False & Misleading Claims Los Angeles District Office 2013 - 01
Hohberg Poultry Ranch F1/F2 PHS Act/Shell Egg Regulation/Adulterated/Insanitary Conditions Los Angeles District Office 2014 - 04
Hospira Costa Rica Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2016 - 01
Instratek, Incorporated CGMP/QSR/Medical Devices/Adulterated Dallas District Office
IsoAid, L.L.C. CGMP/QSR/Adulterated Florida District Office
Marks Marine Pharmacy Unapproved and Misbranded New Drugs Center for Drug Evaluation and Research
Merge Healthcare CGMP/QSR/Medical Devices/Adulterated New Orleans District Office
PruTect Rx New Drug/Labeling/Misbranded Denver District Office 2013 - 08
TCM Supply Corporation CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Trinity Sports Group, Inc. New Drug/Labeling/Misbranded Dallas District Office
Yang Ming Industry (Zhejiang) Limited Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2013 - 01
A Nelson & Co., Ltd. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research 2016 - 05
AireRx Healthcare, LLC CGMP for Medical Devices/QSR/Adulterated/Misbranded New Orleans District Office
Arriol International Corp. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2013 - 05
Augustine Biomedical & Design, LLC Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Bob's Red Mill Natural Foods, Inc. Labeling/False & Misleading Claims/Misbranded Seattle District Office
Commed, Inc CGMP for Medical Devices/QSR/Adulterated/Misbranded Seattle District Office
Gooten Innolife Corp Adulterated Device/Misbranded Center for Devices and Radiological Health
Grato, Inc. CGMP for Finished Pharmaceutical/Unapproved New Drugs/Adulterated/Misbranded Kansas City District Office
Horiba Instruments, Inc dba Horiba Medical Premarket Approval/Adulterated/Misbranded Los Angeles District Office 2013 - 07
Infupharma, LLC CGMP for Finished Pharmaceutical/Adulterated Florida District Office 2013 - 06
Jiangsu Province Jianerkang Medical Dressing Co. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2014 - 11
Meditech Kft. Adulterated Device/Misbranded Center for Devices and Radiological Health 2015 - 06
Medtronic, Inc. CGMP/QSR/Medical Devices/Adulterated Minneapolis District Office
Ningbo Huahui Medical Instruments Co., LTD CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Quanta Aesthetic Lasers USA, LLC Premarket Approval/Misbranded Center for Devices and Radiological Health
Royal King Infant Products Co., Ltd. Adultered Device/Misbranding  Center for Devices and Radiological Health
Sanderlin, Damien MD Clinical Investigator Center for Biologics Evaluation and Research
Shijiazhuang Pharma. Group Zhongnuo Pharmaceuticals Co. Ltd CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research
Sybron Dental Specialties Premarket Approval/Adulterated Center for Devices and Radiological Health 2012 - 10
Zarda Foods LLC CGMP/Manufacture/Packing/Storage/Installation/Adulterated Kansas City District Office
Acclarent, Inc. CGMP/QSR/Medical Devices/Adulterated San Francisco District Office 2014 - 01
Alistrol Health New Drug/Labeling/False & Misleading Claims/Misbranded Seattle District Office
American· Optisurgical Inc. CGMP/QSR/Medical Devices/Adulterated Los Angeles District Office
Apia Enterprise Inc Medical Device Reporting/Misbranded Los Angeles District Office
Compania Internacional de Comercio, S.A. de C.V. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Covidien LP CGMP/QSR/Medical Devices/Adulterated New England District Office 2013 - 04
Dongguan Yongrong Plastic Products Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health
Ercros S.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2016 - 03
Family Beginnings, PC Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products Detroit District Office 2012 - 12
Foshan R. Poon Medical Products Co., Ltd. Adulterated Device/Misbranded Center for Devices and Radiological Health 2015 - 04
Grimm Scientific Industries CGMP for Medical Devices/QSR/Adulterated/Misbranded Cincinnati District Office
Guangdong Baihe Medical Technology Co., Ltd Adulterated Device Center for Devices and Radiological Health 2013 - 07
Hemofarm A.D. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2016 - 04
LAPBANDVIP.com Medical Device/Misbranded Center for Devices and Radiological Health
Oklahoma Respiratory Care, Inc. CGMP for Finished Pharmaceuticals/Adulterated Dallas District Office
Pinook-USA Medical Device/Adulterated/Misbranded Florida District Office
RI. MOS S.R.L. Adulterated Device Center for Devices and Radiological Health
Rol-rom Foods Labeling/False & Misleading Claims/Misbranded New Jersey District Office 2014 - 08
Shamrock Medical Solutions Group LLC CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Cincinnati District Office
Siemens Healthcare Diagnostics, Inc. CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2013 - 01
Advanced OrthoPro, Inc. CGMP/QSR/Medical Devices/Adulterated Detroit District Office 2015 - 12
Albert Browne Ltd. Adulterated Device Center for Devices and Radiological Health
Argentum Medical LLC Misbranding Center for Devices and Radiological Health
Arrowhead DE LLC, DBA Arrowhead Medical Device Technologies CGMP/QSR/Medical Devices/Adulterated New Orleans District Office 2013 - 04
Best Price Rx Unapproved/Misbranded New Drug Center for Drug Evaluation and Research 2012 - 06
C.I. Farmacapsulas S.A. Failure to Register and List Center for Drug Evaluation and Research 2012 - 11
Changzhou Wujin Zhengping Shuangma Chemical Plant CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Center for Drug Evaluation and Research
Copan ltalia Device/Adulterated Center for Devices and Radiological Health 2015 - 02
DMC Medical Ltd CGMP for Medical Devices/QS/Adulterated Center for Devices and Radiological Health
Faci S.P.A. Failure to Register and List Center for Drug Evaluation and Research 2012 - 06
Gramercy Fertility Services Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products New York District Office 2012 - 08
Houser, Elizabeth E. MD Clinical Investigator Center for Drug Evaluation and Research
Malcolm, Matthew PhD., OTR Sponsor-Investigator Center for Devices and Radiological Health
Mc-NEIL-PPC, Inc. Adulterated Device New Jersey District Office 2014 - 05
Northwest Pharmacy Unapproved New Drug-Misbranded Center for Drug Evaluation and Research 2012 - 06
Siemens Healthcare Diagnostics CGMP/QSR/Medical Devices/Adulterated New York District Office 2013 - 07
Tango3 LLC CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office
The Lebanon Corp., Inc. CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation Detroit District Office 2013 - 09
Vienna Beauty Products Cosmetics/Adulterated/Misbranded Cincinnati District Office
Apira Science, Inc. Premarket Approval/Adulterated Los Angeles District Office 2015 - 11
Community Blood Centers of Florida, Inc. CGMP/Finished Pharmaceuticals/Adulterated Florida District Office
Community Blood Centers of Florida, Inc. CGMP/Finished Pharmaceuticals/Adulterated/Misbranded Florida District Office
From Fatigued to Fantastic, LLC Unapproved New Drug Promotional Claims/Misbranded Baltimore District Office
H & H Associates Device/Adulterated/Misbranded Baltimore District Office 2012 - 12
Interlectric Corp Premarket Approval/Misbranded Philadelphia District Office 2013 - 11
Naprodis, Inc. Labeling/New Drug/Misbranded Los Angeles District Office
Sal Pharma Failure to Register and List Center for Drug Evaluation and Research 2012 - 05
Selder S.A. de C.V. CGMP/Finished Pharmaceuticals/Misbranded Center for Drug Evaluation and Research 2014 - 03
Tedec-Meiji Fanna, S.A. CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2013 - 06
Thomas E. Young, LLC PHS Act/Violation Center for Biologics Evaluation and Research
Vitality Distributing, Inc. Unapproved New Drugs/Misbranded Cincinnati District Office
Advanced Specialty Pharmacy dba Meds IV Total Parenteral Nutrition(TPN)Drug Products/Adulterated/Misbranded New Orleans District Office
Biomedical Research Institute of America d/b/a BioMed IRB Institutional Review Board (IRB) Center for Biologics Evaluation and Research 2013 - 01
Chinese Peptide Company Failure to Register and List Center for Drug Evaluation and Research 2012 - 05
Christian Hospital Northeast-Northwest Institutional Review Board (IRB) Center for Biologics Evaluation and Research 2012 - 05
H & H Wholesale Services, Inc. CGMP/QSR/Medical Devices/Adulterated/Misbranded Detroit District Office
He Gao Plastic Factory Adulterated Device/Misbranded Center for Devices and Radiological Health 2016 - 12
High Performance Formulas, L.L.C. (HPF, L.L.C.) New Drug/Labeling/Misbranded Philadelphia District Office 2012 - 04
IntelliCell Biosciences, Inc. Current Good Manufacturing Practice(CGMP)/Current Good Tissue Practice(CGTP) Center for Biologics Evaluation and Research
Kentron Health Care, Inc. Medical Device Reporting/Misbranded New Orleans District Office 2012 - 10
Korea Pharma Company Ltd Failure to Register and List Center for Drug Evaluation and Research
LSL Industries, Inc. Quality System Regulation/Adultered Chicago District Office 2012 - 11
Lucero Medical, LLC Device/Adulterated/Misbranded Cincinnati District Office
NeuroTrax Israel Ltd. Premarket Approval/Medical Device/Adulterated Center for Devices and Radiological Health
NuSil Technology LLC CGMP for Active Pharmaceutical Ingredient (API)/Adulterated San Francisco District Office 2012 - 11
Ogenix Corporation CGMP/QSR/Medical Devices/Adulterated Cincinnati District Office 2012 - 09
Orlane S.A. Failure to Register and List Center for Drug Evaluation and Research 2012 - 04
Reproductive Medicine Institute IVF, LLC Deviations from/CFR/Regulations for Human Cells, Tissues & Cellular Products Florida District Office 2014 - 11
Shanghai Shunlong Physical Therapy Equipment Co. CGMP/QSR/Medical Devices/Adulterated Center for Devices and Radiological Health 2015 - 11
ThyssenKrupp Access Manufacturing, LLC CGMP/QSR/Medical Devices/Adulterated Chicago District Office 2012 - 11
UNAM, Facultad De Estudios Superiores Cuautitlan CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
APP Pharmaceuticals, LLC CGMP for Finished Pharmaceuticals/Adulterated New York District Office
Biochem Laboratories Inc. CGMP Regulations for Finished Pharmaceuticals/Adulterated New Jersey District Office 2013 - 11
Edge Biologicals, Inc. CGMP/QSR/Medical Devices/Adulterated New Orleans District Office 2015 - 03
Extremity Medical, LLC Medical Device Reporting Regulation/Adulterated/Misbranded New Jersey District Office 2012 - 11
Fukuda Denshi Co, Ltd CGMP for Medical Devices/QSR/Medical Device Reporting/Misbranded Center for Devices and Radiological Health 2013 - 05
Gulf Pharmaceutical Industries CGMP/Finished Pharmaceuticals/Adulterated, Center for Drug Evaluation and Research
Innovatech Medical Resources L.P. d/b/a Medical Services International (MSI) CGMP/QSR/Medical Devices/Adulterated Dallas District Office
Jenis, Louis G., M.D. Clinical Investigator Center for Devices and Radiological Health
Life Recovery Systems HD, LLC CGMP/QSR/Medical Devices/Adulterated New Jersey District Office 2012 - 09
Lucomed Spa CMGP for Medical Devices/QSR/Medical Device Reporting/Misbranded Center for Devices and Radiological Health
Medica-Rents Co., Ltd. CGMP/QSR/Medical Devices/Adulterated Dallas District Office 2013 - 01
Merck Sharp and Dohme Corp. Postmarket Requirements (PMRs) Center for Drug Evaluation and Research 2013 - 02
Omron (Dalian) Co., Ltd. Plant 1 CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated Center for Devices and Radiological Health 2017 - 06
Pan Drugs Limited Failure to Register and List Center for Drug Evaluation and Research 2012 - 10
Prosec Protection Systems, Inc. CGMP for Medical Devices/QS/Adulterated New Jersey District Office
Schwabe North America, Inc. Unapproved new drug/Misbranded Minneapolis District Office
Scottcare Corporation CGMP/QSR/Medical Device Reporting/Adulterated Cincinnati District Office 2012 - 08
Shanghai Apolo Medical Technology Co., Ltd Adulterated Device Center for Devices and Radiological Health 2014 - 06
Synthes USA HQ, Inc. CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Philadelphia District Office
Vascular Group PLLC Clinical Investigator   Center for Devices and Radiological Health 2012 - 08
Wintac Limited CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research 2014 - 06
BioElectronics Corporation CGMP/QSR/Medical Devices/Adulterated/Misbranded Center for Devices and Radiological Health
Bracco Diagnostics Inc CGMP/Finished Pharmaceuticals/Adulterated New Jersey District Office
CAW Industries, Inc. Labeling/Misbranded Minneapolis District Office 2013 - 04
LifeSouth Community Blood Centers, Inc. CGMP for Blood & Blood Products/Adulterated New Orleans District Office
LushLife Gardens Unsanitary Conditions/Adulterated New Jersey District Office 2013 - 04
Merit Medical Ireland Ltd. Premarket Approval/Adulterated Center for Devices and Radiological Health 2012 - 10
Mushroom Wisdom, Inc. False & Misleading Claims/New Drug New Jersey District Office
PhotoMedex, Inc. CGMP/QSR/Medical Devices/Adulterated Philadelphia District Office 2013 - 03
Shandong Zibo Shanchuan Medical Instrument Co. Ltd. CGMP for Medical Devices/QSR/Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Spinal Solutiions, LLC CGMP/QSR/Adulterated/Misbranded Los Angeles District Office
Zhejiang Xianju Chemical Pharmaceutical Factory Failure to Register and List Center for Drug Evaluation and Research
Moor Instruments Ltd Quality System Regulation for Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
Orion Vision Group CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated Atlanta District Office
Creative Bioscience, LLC Homeopathic HCG Initiative Center for Drug Evaluation and Research
Sunnyside Poultry Farms PHS Act/Shell Egg Regulation/Adulterated Baltimore District Office
Xylo Chem Industries CGMP/Finished Pharmaceuticals/Adulterated Center for Drug Evaluation and Research
Electro Medical, Inc. Current Good Manufacturing Practice/Adulterated Dallas District Office
Endurance Products Company, Inc. Promotional Claims False & Misleading/New Drugs Seattle District Office
Parker, Norva R Current Good Manufacturing Practice Regulation/Adulterated Dallas District Office
AM2 PAT, Inc Quality System Regulation/Adulterated Atlanta District Office
Arrow International, Inc. Current Good Manufacturing Practice (CGMP) Adulterated/Misbranded Dallas District Office
Boston Scientific Corporation Current Good Manufacturing Practice (CGMP) requirements for medical devices/adulterated New England District Office
Boston Scientific Corporation Quality System Regulation/Adulterated New York District Office
Haidylena for Advanced Medical Industries Current Good Manufacturing Practice Regulation/Adulterated Center for Devices and Radiological Health
Huntsville Hospital Institutional Review Committee Institutional Review Board (IRB) Center for Devices and Radiological Health
I.V. Flush, LLC Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated Dallas District Office
Keeler's Medical Supply, Inc. Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Seattle District Office
Cape Drugs Pharmacy Compounding/New Drug/Misbranded Center for Drug Evaluation and Research
Cytogen Corporation Labeling/Promotional Claims False & Misleading/Misbranded Center for Drug Evaluation and Research
Mark A. Frankle, M.D. Clinical Investigator Center for Devices and Radiological Health
Mark A. Mighell, M.D. Clinical Investigator Center for Devices and Radiological Health
Medical Science Products, Inc. Quality System Reguation/Adulterated Cincinnati District Office
Orthometrix, Inc. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Arrow International, Inc. Quality System Reguation/Adulterated New Jersey District Office
Bishop, Clark M.D. Clinical Investigator Center for Drug Evaluation and Research
Hostoffer, Robert W. DO Clinical Investigator Center for Biologics Evaluation and Research
Immunity Today, LLC Promotional Claims/False & Misleading Center for Biologics Evaluation and Research
Jones, Alison M Clinical Investigator Center for Biologics Evaluation and Research
Medtronic Emergency Response System CGMP Requirements for Medical Devices/Adulterated Seattle District Office
Millennium Dental Technologies Inc. Quality System Reguation/Adulterated Los Angeles District Office
Ovation Pharmaceuticals, Inc. Promotional Claims/False & Misleading/Misbranded Center for Biologics Evaluation and Research
Puronyx, Inc. Lacks Premarket Approval/Adulterated Center for Devices and Radiological Health
The Master's Miracle, Inc. Promotional Claims/False & Misleading Minneapolis District Office
C & E GP Specialists Quality System Regulations (QSR) for finished devices/adulterated Los Angeles District Office
Electrologic of America, Inc. Quality System Regulation/Adulterated Cincinnati District Office
Gate Gourmet, Inc. Interstate Conveyance Sanitation Regulations San Francisco District Office
J D Heiskell & Co CGMP/Adulterated Los Angeles District Office
Philips Medizin Systeme Gmbh CGMP/Adulterated Center for Devices and Radiological Health
Winters, Charles J., M.D. Clinical Investigator Center for Devices and Radiological Health
Catch Incorporated CGMP/QSR/Medical Device Reporting/Adulterated Seattle District Office
Dotolo Research Corporation Quality regulations/Medical Device Reporting regulations/adulterated/misbranded Florida District Office
Grubbs, Gerald L., M.D. Clinical Investigator Center for Devices and Radiological Health
Rosenthal, Kenneth J., M.D. Clinical Investigator Center for Devices and Radiological Health
SCI International, Inc. QSR/Medical Devices/Adulterated Baltimore District Office
Surgical Appliance Industries Current Good Manufacturing Practice Regulation/Adulterated Cincinnati District Office
Yadav, Sanjay S., M.D. Clinical Investigator Center for Devices and Radiological Health
DanChem Technologies, Inc. Active Pharmaceutical Ingredient/Adulterated Baltimore District Office
ITO CO. LTD Quality System Regulation/Medical Devices/Adulterated Center for Devices and Radiological Health
Professional Specialties Company CGMP Requirements of the Quality System Regulations/Adulterated New Orleans District Office
USA Chemical, Inc Labeling/Promotional Claims False & Misleading/Misbranded Center for Food Safety and Applied Nutrition
Advanced Bionics Corporation Current Good Manufacturing Practice Regulation/Adulterated Los Angeles District Office
Allergy Laboratories of Ohio, Inc. Current Good Manufacturing Practice Office of Enforcement
Cohen, Richard M.D. Labeling / New Drug Application Atlanta District Office
Diopsys, Inc. Quality System Regulation for Medical Devices/Adulterated New Jersey District Office
Electronic Data Systems Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation Baltimore District Office
Mayne Pharma (USA) Inc. Postmarketing Adverse Drug Experience Reporting Requirements New Jersey District Office
Medelle Corporation Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Merazon Health Products, Inc. Labeling/Promotional Claims False & Misleading/Misbranded Center for Food Safety and Applied Nutrition
Oro Blanco, Inc. Current Good Manufacturing Practice Regulation/Adulterated Denver District Office
R-Garden, Inc. Labeling/False & Misleading Claims/Misbranded Seattle District Office
South Bay OBGYN Mammography Quality Standards Buffalo District Office
Spectrum Laboratories, Inc. CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded Dallas District Office
The Bryan Company, Inc. CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded Los Angeles District Office
The Sporicidin Company Current Good Manufacturing Practice for Medical Devices Baltimore District Office
Baltimore City Health Department Institutional Review Board (IRB) Center for Biologics Evaluation and Research
OASIS Medical, Inc. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Highland Laboratories, Inc. Lacks Approved New Drug Application Seattle District Office
Penn Herb Co Ltd. Labeling/Promotional Claims False & Misleading/New Drug/Misbranded Philadelphia District Office
Arjo Med. AB Ltd. Current Good Manufacturing Practice/Adulterated Center for Devices and Radiological Health
Chi Machine International Labeling/New Drug/False & Misleading Claims/Misbranded Center for Food Safety and Applied Nutrition
Cincinnati Sub-Zero Products Quality System Regulation/Adulterated/Misbranded Cincinnati District Office
Essential Pharmacy Compounding Pharmacy Compounding/Adulterated Kansas City District Office
Faaborg Rehab Technic ApS Current Good Manufacturing Practice/Adulterated Center for Devices and Radiological Health
Greenland, Inc. Labeling/False & Misleading Claims/Misbranded Seattle District Office
Heel Inc. Promotional Claims/False & Misleading/Misbranded Center for Biologics Evaluation and Research
Ionetics Labeling/Promotional Claims False & Misleading/New Drug Center for Food Safety and Applied Nutrition
Nabi Biopharmaceuticals Labeling/False & Misleading Claims/Misbranded Center for Biologics Evaluation and Research
Peter Schiff Enterprises Current Good Manufacturing Practice/Adulterated New Orleans District Office
Quantum Inc Labeling/New Drug/False & Misleading Claims/Misbranded Center for Food Safety and Applied Nutrition
Thinking Systems Corp. Quality System Regulation/Adulterated/Misbranded Florida District Office
United Healthcare Laboratories Labeling/New Drug/False & Misleading Claims/Misbranded Center for Food Safety and Applied Nutrition
Bennett Industries, Incorporated Current Good Manufacturing Practice for Medical Devices New Orleans District Office
CEPH International Corporation CGMP/Adulterated San Juan District Office
Healthwest Mineral Labeling/Promotional Claims False & Misleading/New Drug/Misbranded Seattle District Office
Hydroderm Labeling/Promotional Claims False & Misleading/New Drug Center for Food Safety and Applied Nutrition
IFC International Medical Devices/Adulterated/Misbranded Chicago District Office
Lobob Laboratories Inc. CGMP Requirement of the Quality System Regulation for Medical Device San Francisco District Office
Nephron Pharmaceuticals Corp CGMP for Finished Pharmaceuticals/Postmarketing Adverse Drug Experience/Adulterated Florida District Office
Parent, J. Rex, M.D. Clinical Investigator Center for Devices and Radiological Health
ReGen Biologics Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Sunshine Packing & Noodle Co., Inc Labeling/Misbranded Florida District Office
Syntee Scientific Corp. CGMP Medical Device Reporting/Adulterated/Misbranded Center for Devices and Radiological Health
The Old Path Natural Herbs Inc Labeling/Promotional Claims False & Misleading/New Drug/Misbranded Florida District Office
Tyco Healthcare Group Current Good Manufacturing Practice Regulation/Adulterated San Francisco District Office
Visual Telecommunications Network, Inc. Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated Baltimore District Office
Alpha Omega Manufacturing, Inc. Current Good Manufacturing Practice Regulation/Adulterated Dallas District Office
Beverly Hills Prostetics Orthotics, Inc. Current Good Manufacturing Practice/Adulterated Los Angeles District Office
Efoora, Inc. Sponsor/Monitor/Contract Research Organization Center for Biologics Evaluation and Research
Enzymology Research Center, Inc. Labeling/Promotional Claims False & Misleading/Misbranded Minneapolis District Office
Estill Medical Technologies, Inc. Current Good Manufacturing Practice Regulation/Adulterated Dallas District Office
Furst McNess Company Current Good Manufacturing Practice for Medicated Feeds/Adulterated Cincinnati District Office
Gottlieb, Michael S., M.D. Clinical Investigator Center for Biologics Evaluation and Research
Lifestream Medical Corporation Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
Mackie International, Inc. False & Misleading Claims/Misbranded Los Angeles District Office
Octapharma USA, Inc. Labeling/Promotional Claims False & Misleading/Misbranded Center for Biologics Evaluation and Research
Oklahoma Blood Institute Current Good Manufacturing Practices for Blood & Components/Adulterated Dallas District Office
Saliva Diagnostic Systems, Inc. Sponsor/Monitor/Contract Research Organization Center for Biologics Evaluation and Research
Similasan AG Cuurent Good Manufacturing Practice/Adulterated/Misbranded Center for Drug Evaluation and Research
Southern Implants, LLC Current Good Manufacturing Practice Regulation/Adulterated Center for Devices and Radiological Health
Tepnel Diagnostics Ltd. Lacks Premarket Approval Application Adulterated Center for Devices and Radiological Health
Tyco Healthcare Group Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation Center for Devices and Radiological Health
Ulrich GmbH & Co. KG Current Good Manufacturing Practice/Adulterated/Misbranded Center for Devices and Radiological Health
Universal Nutraceuticals, Inc. Labeling/Promotional Claims False & Misleading/New Drug Baltimore District Office
Access Genetics Lacks Premarket Notification Approval/Adulterated/Misbranded Center for Devices and Radiological Health
ACS Dobfar Current Good Manufacturing Practice Regulation/Adulterated Center for Drug Evaluation and Research
American Medical Specialties, Inc. Quality System Regulation for Medical Devices/Adulterated/Misbranded Florida District Office
Beam of Light Technologies, Inc. Laser Product Performance Standard/Labeling Center for Devices and Radiological Health
Beck Network, Inc. Promotional Claims False & Misleading/New Drugs New Orleans District Office
BioMerieux, Inc. CGMP/IVR Manufacturing Office of Enforcement
ElderTech Solutions, LLC Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated Seattle District Office
Halstead Springs, Inc. CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated New Orleans District Office
Hitachi Medical Systems America, Inc. Medical Device Reporting (MDR) Regulation Misbranded/Adulterated Cincinnati District Office
Merck & Company, Inc. Biologics License/Adulterated Office of Enforcement
Mercy Health System of Kansas, Inc. Current Good Manufacturing Practices for Blood and Blood Components Kansas City District Office
MJM International Corporation CGMP/QSR/Lacks Premarket Approval Application/Medical Device Reporting Regulation Dallas District Office
SenoRx, Inc. CGMP Requirements for Medical Devices/Adulterated Los Angeles District Office
Superior Rehab Technology, Inc. Current Good Manufacturing Practice/Adulterated/Misbranded Dallas District Office
Uroplasty, Inc. Sponsor/Monitor/Contract Research Organization Center for Devices and Radiological Health
American Thermal Instrument Inc. Quality System Reguation/Adulterated Cincinnati District Office
Arrow International, Inc. CGMP/Adulterated Philadelphia District Office
Bimeda MTC Animal Health Inc. Current Good Manufacturing Practice Regulation/Adulterated Center for Veterinary Medicine
Con-Med Corporation Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded Florida District Office
Coutts, Richard M.D. Clinical Investigator Center for Devices and Radiological Health
CrestLab Inc. Current Good Manufacturing Practice/Adulterated Detroit District Office
Custom Ultrasonics, Inc. Current Good Manufacturing Practice Regulation/Adulterated Seattle District Office
Georgia Biomedical, Inc. Quality System Reguation/Adulterated Atlanta District Office
Global Manufacturing & Engineering, LLC Current Good Manufacturing Practice/Adulterated New Orleans District Office
Greer Laboratories, Inc. CGMP for Finished Pharmaceutical Office of Enforcement
Khoury, Michael MD Clinical Investigator Center for Devices and Radiological Health
Lake Erie Medical and Surgical, Inc. Current Good Mfg Practice Regulation/Adulterated/Misbranded Detroit District Office
Lee Medical International, Inc. CGMP for Medical Devices/QSR/Adulterated/Misbranded New Orleans District Office
MedImmune Vaccines, Inc. Labeling/Promotional Claims False & Misleading/Misbranded Center for Biologics Evaluation and Research
MedTec Inc QSR/Medical Devices/Adulterated Kansas City District Office
Mercy Medical Center Current Good Manufacturing Practices for Blood and Blood Components Kansas City District Office
Pragmatic Materials, Inc. Active Pharmaceutical Ingredient/Adulterated Cincinnati District Office
St. John Hospital IRB Institutional Review Board (IRB) Center for Devices and Radiological Health
Biolmagene, Inc. Lacks Approved Premarket Application/Adulterated Center for Devices and Radiological Health
Bioteque America, Inc. Current Good Manufacturing Practice Regulation/Adulterated Philadelphia District Office
Boston Scientific Corporation Current Good Manufacturing Practice Regulation/Adulterated New England District Office
C & M Oxyfill, LLC Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated New Orleans District Office
Cohen, Daniel, M.D. Clinical Investigator Center for Biologics Evaluation and Research
Constantine, Neil T Ph.D Clinical Investigator Center for Biologics Evaluation and Research
Koppes, Thomas P Clinical Investigator Center for Biologics Evaluation and Research
Nucura Pharmaceuticals, Inc. Labeling/False & Misleading Claims/New Drug/Misbranded Los Angeles District Office
Pascal Company, Inc. Current Good Manufacturing Practice Regulation/Adulterated Seattle District Office
Spectronics Corporation Quality System Regulation for Medical Devices/Adulterated New York District Office
Telex Communications, Inc. Quality System Regulation/Medical Device Reporting Regulation/Misbranded/Adulerated Kansas City District Office
UAS Laboratories Labeling/False & Misleading Claims/Misbranded Minneapolis District Office
Alcon Laboratories, Inc. Current Good Manufacturing Practice Regulation/Adulterated Florida District Office
Convatec Quality System Regulation/Adulterated New Jersey District Office
Digicare Biomedical Technology, Inc. Quality System Reguation/Adulterated Florida District Office
Inoveon Corporation Current Good Manufacturing Practice Regulation/Adulterated Dallas District Office
Oconee Memorial Hospital Current Good Manufacturing Practices for Blood & Components/Adulterated Atlanta District Office
Pace Tech, Inc. Quality System Regulation/Adulterated Florida District Office
PIE Medical International, Inc. Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded Atlanta District Office
Two Feathers, Inc. Promotional Claims False & Misleading/Unapproved New Drug/Misbranded San Francisco District Office
Wilbur Ellis Company CGMP/Adulterated Denver District Office
ZooScape.com Promotional Claims/False & Misleading/Misbranded Center for Biologics Evaluation and Research
Advantage Nutraceuticals, LLC Labeling/False & Misleading Claims/New Drug Florida District Office
Alternative Health & Herb Remedies Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded Seattle District Office
Assistive Technology, Inc. Quality System Regulation/Adulterated/Misbranded Detroit District Office
Baxter Healthcare Corporation Current Good Mfg Practice Regulation/Adulterated/Misbranded Florida District Office
Cafeteria Adelita Import/Lacks Florida District Office
Cameron Regional Medical Center Current Good Manufacturing Practices for Blood and Blood Components Kansas City District Office
F. Vericat Cadesas Promotional Claims/False & Misleading/Misbranded Center for Biologics Evaluation and Research
Flotec, Inc. Current Good Manufacturing Practice Regulation/Adulterated Detroit District Office
General Electric, Inc. Quality System Regulation for Medical Devices/Adulterated Denver District Office
Hamilton Medical AG Good Manufacturing Practices / Quality System Regulations Center for Devices and Radiological Health
Palace Pharmacy Pharmacy Compounding/Misbranded Denver District Office
Patient First Corporation Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Baltimore District Office
Sami A. Yanikian M.D. Promotional Claims/False & Misleading/Misbranded Los Angeles District Office
Silent Call Communications Corp. Quality System Regulation/Adulterated Detroit District Office
St Jude Medical, Inc. Quality System Regulation for Medical Devices/Adulterated San Juan District Office
Tosoh Bioscience, Inc. Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated San Francisco District Office
Tropical Traditions, Inc. Labeling/New Drug/False & Misleading Claims/Misbranded Minneapolis District Office
Weil, Lowell S. Sr., D.P.M. Clinical Investigator Center for Devices and Radiological Health
William A. Gray, M.D. Clinical Investigator Center for Devices and Radiological Health
Alva Jade Enterprises, Inc. Labeling/Promotional Claims False & Misleading/New Drug Florida District Office
Animas Corporation CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated Philadelphia District Office
Healthy World Distributing, LLC Lachs Approved Biologic License Application Center for Biologics Evaluation and Research
Icon Interventional Systems, Inc. Import for Export/Lacks Premarket Approval Cincinnati District Office
Medsep Corporation GMP for the Quality system Regulation/CGMP for Finished Pharmaceuticals/Adulterated Los Angeles District Office
Nichols, Trent. M.D. Clinical Investigator Center for Devices and Radiological Health
Organic Pastures Dairy Company Control of Communicable Disease San Francisco District Office
Quality Liquid Feeds Current Good Manufacturing Practice for Medicated Feeds/Adulterated Cincinnati District Office
Subcon Manufacturing Corporation QSR/Medical Devices/Adulterated Chicago District Office
Tennant, Jerald L., M.D. Clinical Investigator Center for Devices and Radiological Health
Two Rivers LLC CGMP Requirements of the Quality System Regulations/Adulterated New Orleans District Office
Tyco Healthcare Group CGMP Requirements of the Quality System Regulations/Adulterated Center for Devices and Radiological Health
Archer Daniels Midland Company CGMP/Medicated Feeds/Adulterated Kansas City District Office
Basic Research, LLC Labeling/Promotional Claims False & Misleading/New Drug Denver District Office
Basic Research, LLC Labeling/Promotional Claims False & Misleading/New Drug Denver District Office
Crittenton Hospital Medical Center Institutional Review Board (IRB) Center for Devices and Radiological Health
E-Lyte Incorporated New Drug/Labeling/False & Misleading Claims New Jersey District Office
Marcum, John W., M.D. Clinical Investigator Center for Devices and Radiological Health
Created by : -webliska