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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
AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Tyche Industries Ltd Center for Drug Evaluation and Research (CDER) CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jagsonpal Pharmaceuticals Limited Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
ABR Laboratory LLC Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
Marshalls Traditional Healthcare CC Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/Adulterated
Zenzi Pharmaceutical Industries Pvt. Ltd. Center for Drug Evaluation and Research (CDER) Refusal to Provide Access to and Copying of Records
Robbins Instruments, LLC "ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality" Medical Device/Misbranded/Unapproved Device/Quality System Regulation
Walker Enterprises, LLC d/b/a MaddCatt Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Steep Slope Vape Supply Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Route 66 Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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