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 |
|---|---|---|---|---|---|---|
| Innova Medical Group, Inc. | Center for Devices and Radiological Health | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
| Perfection Vapes Inc | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Neptunus Seafood B.V. | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | ||||
| Kareem Mart Inc. | Div ision of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | ||||
| DMM Vission, S.A. de C.V. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | ||||
| Red's Kitchen Sink at Bourbon Street Ice | Office of Human and Animal Food Operations – East Division 3 | New Drug/Misbranded |
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| Everything Health LLC | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019(COVID-19) | ||||
| Beauty & Spa Concepts, DBA Beenefits | Center for Food Safety and Applied Nutrition | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||||
| PurePurge Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
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| Castle Rock Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |