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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
Vaporwave LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
You Suck Vapes Altus Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Brigham and Women’s Hospital Inc. Office of Pharmaceutical Quality Operations Division I CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
MCACO, LTD Division of Human and Animal Food Operations West III CGMP/Dietary Supplement/Adulterated
Purina Animal Nutrition LLC Division of Human and Animal Food Operations West III CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Inhousepharmacy.vu Center for Drug Evaluation and Research | CDER Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
Beachside Vapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
David Cosmetic Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceutical/Adulterated
Advanced Nutritional Supplements LLC Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated
Exclusive Nutrition Products, LLC Center for Food Safety and Applied Nutrition (CFSAN) Dietary Supplement/Adulterated

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