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 |
|---|---|---|---|---|---|---|---|
| Suretec Innovations, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated and Misbranded | |||||
| Auriga Research Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Waves and Wine, Inc. | Center for Veterinary Medicine | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated | |||||
| Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded |
|||||
| Safrel Pharmaceuticals LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| DeJong Family Dairy, LLC | Center for Veterinary Medicine | New Animal Drug/Adulterated | |||||
| mikuvape.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| giantnic.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
|||||
| Eugia Pharma Specialities Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| K.C. Pharmaceuticals, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |