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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
Grimann S.A. de C.V. Center for Drug Evaluation and Research | CDER Failure to Comply with Drug Registration and Listing Requirements
Yippee Farms, LLC Division of Human and Animal Food Operations East II Illegal Drug Residue Animal Tissue/Adulterated
OsteoLife Biomedical I LLC Office of Biological Products Operations – Division I Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
New Vitalis, LLC dba New Vitalis Pharmacy Division of Pharmaceutical Quality Operations III Compounding Pharmacy/Adulterated Drug Products
CAJ Food Products Inc. Office of Human and Animal Food Operations East Division 6 New Drug/Misbranded
Russ Davis Wholesale Inc Office of Human and Animal Food Operations - West Division 1 Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Freeman and Biddy, LLC d/b/a Freedom Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Wick ‘N’ Vape, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Hope Botanicals, LLC Center for Veterinary Medicine Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
Plantacea, LLC dba Kahm Center for Veterinary Medicine Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products

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