Select 483 Files

Here we have select 483s files from the FDA.

View select 483 forms below, Let Us Know if You Need a Different One!

A FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

Firm Name Record Date (DD-MM-YR) Country
Strides Shasun Limited 26-05-2017 India
Lupin Limited 19-05-2017 India
Dr. Reddy's Laboratories 28-04-2017 India
Aurobindo Pharma Ltd. Unit IV 28-04-2017 India
Torrent Pharmaceuticals Limited 28-04-2017 India
Aurobindo Pharm Ltd. Unit 3 18-04-2017 India
Fresenius Kabi Oncology Limited (Baddi) 14-04-2017 India
Sun Pharmaceutical Industries Ltd. 13-04-2017 India
Biocon Limited 07-04-2017 India
Lupin Limited 07-04-2017 India
Dr. Reddy's Laboratories Unit 6 04-04-2017 India
Fresenius Kabi USA, LLC 30-03-2017 Grand Island, NY
Alkem Laboratories Limited 10-03-2017 India
Dr. Reddy's Laboratories 08-03-2017 India
Cadila Healthcare Limited 01-03-2017 India
Dr. Reddy's Laboratories 21-02-2017 India
Fresenius Kabi USA, LLC 01-02-2017 Grand Island, NY
Teva Pharmaceuticals USA, Inc. 01-02-2017 USA
Mylan Laboratories Limited 01-02-2017 India
Natco Pharma Limited 24-01-2017 India
Hetero Labs Limited 16-12-2016 India
Granules 09-12-2016 India
Divi's Laboratories 06-12-2016 India
Sun Pharmaceutical Industries Ltd. 01-12-2016 India
Sun Pharmaceuticals Industries, Inc. 16-11-2016 India
Aurobindo Pharma Unit 1, Telangana 25-10-2016 India
Alkem Laboratories Limited 29-09-2016 India
Aurobindo Pharma Limited Unit 4 16-09-2016 India
Indoco Remedies Limited 04-09-2016 India
Cipla Limited 30-08-2016 India
Claris Injectables Limited 26-08-2016 India
Badrivishal Chemicals & Pharmaceuticals 19-08-2016 India
Sanofi Winthrop Industrie 19-07-2016 France
Lupin Limited 17-07-2016 India
Lupin Limited 06-07-2016 India
Aurobindo Pharma Limited Unit 8 01-07-2016 India
Sekisui Medical 17-06-2016 Japan
Alembic Pharmaceuticals Limited 25-03-2016 India
Teva Pharmaceutical Works Private Limited Company 29-01-2016 Hungary
Cosma SpA 15-01-2016 Italy
Wockhardt Limited 15-12-2015 India
CP Pharmaceuticals 13-10-2015 United Kingdom
Zhejiang Medicine Co. 18-06-2015 China

Are you new to 483 forms? An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts