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 |
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Fancystage Unipessoal, LDA | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||||
Toltrazuril Shop | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
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Linessa Farms, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
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Cosmetic Solutions, LLC | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
Midwest Foods, LLC | Division of Human and Animal Food Operations West II | Acidified Foods/Prepared Packed or Held Under Insanitary Conditions |
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End of Translation |
TCT Nutraceuticals SDN. BHD | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | ||||
totaltoltrazuril.com | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
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Big Island Candies, Inc. | Division of Human and Animal Food Operations West V | CGMP Food Labeling/Misbranded/Adulterated |
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All Things Bunnies, Inc. | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated |
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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 |