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 |
|---|---|---|---|---|---|---|---|
| Abbott Diabetes Care, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Cohance Lifesciences Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Flextronics America LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| The Great Smart African Food LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| gotpouches.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
|||||
| HTO Nevada, Inc. dba Kirkman | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Carolina Seafood Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated | |||||
| Christopher Dale Butler | Human Foods Program | Acidified Foods/Emergency Permit Control/Adulterated | |||||
| CC Pollen Company | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | |||||
| Eniva USA, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded |