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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
Ram Goods LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Euro USA Inc Division of Human and Animal Food Operations East V Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
EPD International S.R.O. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
La Sucursal Produce Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
Appleton City Feed Service LLC Division of Human and Animal Food Operations West II CGMP/Medicated Feeds/Adulterated
Master Paints & Chemicals Corp. Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
Natco Pharma Limited Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Soulaire Corporation Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
C&T Dream Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Kai’s Virgin Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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