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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
Vegewax Candleworx Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
Mehran Michael Bahrami, M.D. Center for Drug Evaluation and Research (CDER) Clinical Investigator
Advanced Pharmaceutical Technology Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
Red Oak Instruments, LLC Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Rite-Kem Incorporated Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Waxhead Sun Defense Company Center for Drug Evaluation and Research (CDER) OTC/Unapproved New Drug/Misbranded
Aspen Pharmacare Holdings Limited Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
Zacanta LLC Office of Inspections and Investigations Foreign Supplier Verification Program (FSVP)
Kabana Skin Care Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
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