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 |
|---|---|---|---|---|---|---|---|
| Liquivape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Switch to Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Noble Elements, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||||
| Organic Heirloom Plants | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||||
| Dr. Green Mom, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
|||||
| RightEye, LLC | Division of Medical Device and Radiological Health Operations East | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Urban Electric Power | Division of Pharmaceutical Quality Operations I | CGMP/Drug Products/Adulterated | |||||
| Mohawk Laboratories Division of NCH Corporation | Division of Pharmaceutical Quality Operations II | CGMP/Drug Products/Adulterated | |||||
| Old Tiles Wallpaper, LLC DBA Old Tiles Decor | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||||
| Monkeypox-treatment.com | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |