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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
Elk River Vapor Shop Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
The Vapor Club LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Garcia Fresh Vegetables LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
Sperm Bank, Inc. dba Fertility Center of California Center for Biologics Evaluation and Research (CBER) Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Loveli Design, LLC d/b/a Alice in Vapeland Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Radhaswamy Inc. dba Raja Foods LLC Division of Northeast Imports Foreign Supplier Verification Program (FSVP)
Marshalls Traditional Healthcare CC Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceutical/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
Zenzi Pharmaceutical Industries Pvt. Ltd. Center for Drug Evaluation and Research (CDER) Refusal to Provide Access to and Copying of Records
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