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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  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
Top Health Manufacturing, LLC Division of Human and Animal Food Operations West IV CGMP/Dietary Supplement/Adulterated
Armstrong County Memorial Hospital Center for Drug Evaluation and Research (CDER) Institutional Review Board (IRB)
Fancy Drops Beauty LLC Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Analytical Food Laboratories, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Ardent Animal Health, LLC Center for Veterinary Medicine Unapproved New Animal Drug Products
Modern Smoking Solutions, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Liquid Nics LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Nexus Smoke Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
eCig Distributors, Inc. d/b/a eJuices.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Morevaping Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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