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 |
|---|---|---|---|---|---|---|---|
| Hookies and Bookies | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Fantasia Distribution Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| D&C Seafood, Inc | Division of Human and Animal Food Operations East V | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Picket Fence Creamery LLC | Division of Human and Animal Food Operations West II | Food Labeling/Misbranded | |||||
| OFP Ingredients LLC | Division of Human and Animal Food Operations West I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| VHRK Food Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Ding Tea Balboa | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| 5,000 Years Foods, Inc. | Office of Human and Animal Food Operations, East Division VI | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Vapor Candy, LLC d/b/a The Vape Stop | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Frozen Wheels, LLC | Division of Pharmaceutical Quality Operations II | Drug Product/Adulterated |