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 |
|---|---|---|---|---|---|---|---|
| Trexo Robotics Holdings Inc. | "OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality" | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device, Misbranded | |||||
| Baja Best Distributing, Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Techlem Medical Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
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| Smoke Shop Direct Dist, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Biomic Sciences, LLC dba ION Intelligence of Nature | Division of Human and Animal Food Operations East II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| 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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| 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 | |||||
| Genpro Imports & Export Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |