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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
Viatris, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Anne’s Daye Ltd dba Tampon Innovations Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Rontis Hellas S.A. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
Akron Formulations India Private Limited Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
Sombra Cosmetics, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Brands International Corporation Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated/Refusal to Allow Inspection
E-liquid Brands, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
JBRANDS LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Chris Brown Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Vape Mania Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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