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 |
|---|---|---|---|---|---|---|---|
| Elanco Animal Health USA | Center for Veterinary Medicine | False & Misleading Claims/Misbranded | |||||
| Cosmetic Manufacturers Pty Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Fidelity Melon, Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Bertrand P. Cole, D.O./Activmed Practices and Research, LLC | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Central Coast Multispecialty Medical Group, Inc. | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| BNC Distribution Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Mark S. Dacey, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Maui Seafood LLC | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Bio-Medical Pharmaceutical Manufacturing Corporation | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Signature Formulations, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |