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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
Dollar Tree Inc. Center for Food Safety and Applied Nutrition (CFSAN) Adulterated Human Foods
Aqualex Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated
Landy International Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Angela D. Ritter, M.D. Center for Drug Evaluation and Research | CDER Clinical Investigator (Sponsor)
McClure’s Lancaster Old Fashioned, LLC Division of Human and Animal Food Operations East II CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
VP Global, LLC d/b/a Super Vape Pirates Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Premier Manufacturing Products, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug
Neobiosis, LLC Division of Biological Products Operations I Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
GFA Production Xiamen Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Chang and Son Enterprises, Inc. Division of Human and Animal Food Operations East I CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes

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