Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Bharat Overseas Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Macau-Union Pharmaceutical Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drugs/Misbranded | |||||
| Revlon Group Holdings, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| PLZ Corp | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| Jose M. Carpio, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Gopaldas Visram & Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| Fagron BV | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Umendra Life Sciences Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| Laboratorios Dr. Collado S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| Shantou Qiwei Industry Co., LTD | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated |