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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
Insightra Medical Inc. Center for Devices and Radiological Health Medical Device Reporting/Misbranded
Lystn LLC dba Answers Pet Food Center for Veterinary Medicine CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
J.D. Heiskell Holdings LLC Center for Veterinary Medicine CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
puff21.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
bestvape.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Xtreme Tools International, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Libby Laboratories, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Voehlganic Farm LLC Human Foods Program PHS Act/Shell Egg Regulation/Adulterated
Dynamic Blending Specialists, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Exela Pharma Sciences, LLC Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated

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