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  3. Compliance Actions and Activities
  4. Warning Letters
  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
NatureLab Corp. Division of Pharmaceutical Quality Operations II CGMP/Dietary Supplement/Adulterated
Vape Crusades Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
The Anthos Group, Inc. Center for Drug Evaluation and Research | CDER Refusal to Provide Access to and Copying of Records
Third Synthesis Inc., dba Chicago Sweet Connections, Inc. Division of Human and Animal Food Operations East VI CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Omega & Delta Co., Inc. Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
Abraxis Bioscience LLC Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Vape King, Inc Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Rogue Vapers, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Juicemafia Inc. d/b/a ECIG-Works Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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