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  4. Warning Letters
  1. Compliance Actions and Activities

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.
 


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Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt
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
totaltoltrazuril.com Center for Veterinary Medicine Unapproved New Animal Drug/Adulterated
All Things Bunnies, Inc. Center for Veterinary Medicine Unapproved New Animal Drug/Adulterated
Linessa Farms, LLC Center for Veterinary Medicine Unapproved New Animal Drug/Adulterated
Midwest Foods, LLC End of
Translation Click to Translate text after this point Division of Human and Animal Food Operations West II 		Acidified Foods/Prepared Packed or Held Under Insanitary Conditions
Cosmetic Solutions, LLC Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
TCT Nutraceuticals SDN. BHD Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Big Island Candies, Inc. Division of Human and Animal Food Operations West V CGMP Food Labeling/Misbranded/Adulterated
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
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