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 |
|---|---|---|---|---|---|---|---|
| Brilliant Enterprises LLC | Office of Human and Animal Food Operations Division- East 6 | Unapproved New Drugs/Misbranded | |||||
| McDaniel Water, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| New York Nutrition Company / American Metabolix | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded | |||||
| Weidenhamer and Morin Enterprises LLC d/b/a Liquivape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Chula Vista Imports Ltd. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
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| Radhanite, LLC d/b/a Curalife Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded | |||||
| Aceva, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |
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| Ar-Rahman Pharm LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded | |||||
| Lysulin, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded | |||||
| Phytag Labs | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded |