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  3. Compliance Actions and Activities
  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
Electric Clouds, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Good Smokes LLC, d/b/a Vape N Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Business Trading Company LLC, d/b/a Vapor Tonics Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
A-Z Tobacco Inc, d/b/a A-Z Tobacco Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Cool Vape LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Amazon.com, Inc. Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
C & A Naturistics Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Q’Apel Medical, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Right Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals Center for Drug Evaluation and Research (CDER) Compounding Pharmacy/Adulterated Drug Products
Shree Jaya Laboratories PVT. LTD. Center for Drug Evaluation and Research (CDER) CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
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