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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
Ecig Vapor Juice Store Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Mena Produce LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
El Salvador Products Inc Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Med Pen Concepts, LLC Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded
Vapeoholic LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
GN Tobacco Sweden AB d/b/a White Fox USA Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Muscle Sports Products, LLC Office of Human and Animal Food Operations East – Division 1 Unapproved New Drugs/Misbranded
Zhejiang Tianyu Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Staccato Ventures LLC d/b/a Carolina Vape Kings Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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