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.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Dr. Brite, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Mid America Pet Food LLC | Center for Veterinary Medicine | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Guangzhou Four E’s Scientific Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Knickerbocker 365 Inc. | Office of Human & Animal Food Operations East 6 | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | |||||
| Purcell International | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| WANABANA USA LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Caribbean Produce Exchange, LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| MVRB2, LLC, d/b/a Kure CBD & Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Applied Therapeutics, Inc. | Center for Drug Evaluation and Research (CDER) | Sponsor | |||||
| Han C. Phan, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |