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  4. Warning Letters
  1. Compliance Actions and Activities

Warning Letters

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.

 


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Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt
Nicecloud LLC d/b/a Nicecloud Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
You Suck Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
You Suck Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
You Suck Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Nice Cloud LLC d/b/a/ Nicecloud Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Yangzhou Sion Commodity Co., Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/API/Adulterated
Annovex Pharma, Inc. Center for Drug Evaluation and Research (CDER) Compounding Pharmacy/Adulterated Drug Products
Dexcom, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
Aspen Biopharma Labs Private Limited Center for Drug Evaluation and Research (CDER) CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Hangzhou Glamcos Biotech Co., Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
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