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  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.

 


Posted Date Letter Issue Date Company Name Issuing Office Subject Response Letter Closeout Letter Excerpt
Empower Clinic Services, LLC dba Empower Pharma Center for Drug Evaluation and Research (CDER) Compounding Pharmacy/Adulterated Drug Products
Noah Medical Corporation Center for Devices and Radiological Health CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Livestock Nutrition Center Center for Veterinary Medicine CGMP/Non-Medicated Feed/Adulterated
ICU Medical Center for Devices and Radiological Health CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
hoosierecig.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Eritrean Corporation d/b/a First Choice Pipe Tobacco Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
PMS4PMS, LLC Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Nubratori, Inc. dba Nubratori Rx Center for Drug Evaluation and Research (CDER) Compounding Pharmacy/Adulterated Drug Products
Naturista Store LLC Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
dripcratevapeshop.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

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