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  1. Compliance Actions and Activities

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
Route 66 Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Great Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Reckitt/Mead Johnson Nutrition HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) CGMP/Quality Control/Adulterated/Infant Formula
Perrigo Wisconsin, LLC HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) CGMP/Quality Control/Adulterated/Infant Formula
ByHeart, Inc. HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) CGMP/Quality Control/Adulterated/Infant Formula
Cosmobeauti Laboratories & Manufacturing Inc. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Gadal Laboratories Inc. Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
Victory Trading Company Inc. Division of Human and Animal Food Operations East I CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Essential Research, LLC Center for Veterinary Medicine Unapproved New Animal Drug Products
Tesla BioHealing, Inc. Division of Medical Device and Radiological Health Operations East Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)

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