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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
Smoke-Free Planet, LLC d/b/a Smoke Free Nation Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vape Junkie EJuice Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
7333 LLC Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
Vitae Enim Vitae Scientific Inc. Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
White Horse Vapor Store, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Clinical Resolution Laboratory Inc. Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
Guangzhou Zhongkebaishi Health Industry Co., Ltd. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Fresh Farms LLC Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
Alymar LLC Southwest Imports Foreign Supplier Verification Program (FSVP)
Cetylite Industries, Inc. Division of Pharmaceutical Quality Operations I CGMP/Finished Pharmaceuticals/Adulterated

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