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 |
|---|---|---|---|---|---|---|---|
| Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Sheng Kee of California, Inc dba Sheng Kee Bakery | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Bioptimal International | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" | CGMP/QSR/Medical Devices/Adulterated | |||||
| Augustine Temperature Management, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||||
| Global Cosmetics Company Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Juquilita Mexican Imports LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Always Fresco LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| APG SEVEN, INC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded | |||||
| Jolca, S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated | |||||
| Hunan Gagazui Food Co., Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | Low Acid Canned Food Regulation/Adulterated |
