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 |
|---|---|---|---|---|---|---|---|
| Babikian Healthcare Products CJSC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Stokes Healthcare Inc. dba Epicur Pharma | Center for Veterinary Medicine | Animal Drugs/Adulterated | |||||
| Wellmill, LLC dba Vitamix Laboratories | Human Foods Program | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Bentley Laboratories LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
| Curia New York, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Stream2Sea, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Celmade | Center for Drug Evaluation and Research (CDER) | Review of Website/Unapproved New Drug/Misbranded | |||||
| American Pharma Mfg. Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | |||||
| Good Stuff Cacao | Human Foods Program | New Drug/Misbranded |
|||||
| Bo Wah Enterprises Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |