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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.
  • Frequently requested records may be accessed on the Reading Room page.

 


Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt
Artisan Vapor & CBD Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
The Game Trader Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Kure CBD & Vape Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Dermacare dba Filler Outlet Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded Botox
Korean Aesthetic dba Korean Fillers Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded Botox
Cosmenic Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded Botox
Maypharm Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded Botox
CelestaPro Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded Botox
Estaderma Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded Botox
AceCosm Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded/Botox Blitz

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