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 |
|---|---|---|---|---|---|---|---|
| EC Supply, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| ABS Distribution Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Easy Wholesale, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Stratus Biosystems, LLC dba CellGenuity Regenerative Science | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Northland Vapor Company, LLC | Division of Human and Animal Food Operations West I | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Gadget Island, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| Five Leaf Pet Botanicals, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug Products | |||||
| Koi CBD, LLC | Division of Human and Animal Food Operations West V | Adulterated Human Foods/Misbranded | |||||
| Baits and Sea Foods, S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Wise Women’s Choice | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |