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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.
  • Frequently requested records may be accessed on the Reading Room page.

 


Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt
LyfeUnit / www.lyfeunit.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Ketacyn Pharmaceuticals / www.ketacynpharma.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Extra Medication / www.extramedication.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
All Ketamine HCL / www.allketaminehcl.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Ketamine Troche Store / www.ketaminetrochestore.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Buy Keta Online / www.buyketaonline.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Ketamine Store / www.ketaminestore.org Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Legit Ketamine Suppliers / www.legitketaminesuppliers.com Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
Ketdaxandrugs / www.ketdaxandrugs.org Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded

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