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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
Luis Javier Pena-Hernandez, M.D., FCCP Center for Drug Evaluation and Research | CDER Clinical Investigator
Shot of Joy LLC Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Signature Biologics, LLC Division of Biological Products Operations II Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Fresenius Kabi AG Division of Biological Products Operations I CGMP Deviations 
Oceanitan, Inc. Division of Human and Animal Food Operations West V CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Southern Tier Home Infusion, Inc. dba Pharmacy Innovations Division of Pharmaceutical Quality Operations I Compounding Pharmacy/Adulterated Drug Products
Infinant Health, Inc formerly Evolve Biosystems Inc. Center for Biologics Evaluation and Research (CBER) Unapproved New Drugs/Misbranded
The Vaping Dragon, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Caribbean Cloud Dot Com d/b/a Gorilla Vapes LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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