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 |
|---|---|---|---|---|---|---|---|
| Aruba Aloe Balm N.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||||
| Ostar Beauty Sci-Tech Co Ltd. | OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Safari Stem Cell, LLC | Division of Biological Products Operations II | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
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| Ward Smelling Salts | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
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| Genpro Imports & Export Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Biomic Sciences, LLC dba ION Intelligence of Nature | Division of Human and Animal Food Operations East II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Amin Trading Agency LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Rash Catering Services, LLC | Division of Southwest Imports | FSVP/Seafood HACCP | |||||
| Meditco, Inc. D.B.A. Phoenicia Specialty Foods | Division of Southwest Imports | FSVP/Human and Animal Foods | |||||
| Seatex, LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |