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  1. Compliance Actions and Activities

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
Sichuan Deebio Pharmaceutical Co. Ltd. Center for Drug Evaluation and Research | CDER CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Salvacion USA Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
Vixen Vapors LLC d/b/a Vixen Vapors Pantego Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Curtis Jacquot dba Pacific BioLogic Co. Division of Human and Animal Food Operations West V CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Battle Creek Co-op/CHS, LLC dba Progressive Nutrition Division of Human and Animal Food Operations West II CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated
QuVa Pharma, Inc. Division of Pharmaceutical Quality Operations I Compounding Pharmacy/Adulterated Drug Products
Global Life Technologies Corp. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
US Chem Labs Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Lucky K.T. Co., Inc. Division of Human and Animal Food Operations West V CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Ningbo Poplar Daily-Use Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated

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