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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
Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Augustine Temperature Management, LLC Center for Devices and Radiological Health Medical Device Reporting/Misbranded
Global Cosmetics Company Limited Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
APG SEVEN, INC Division of Human and Animal Food Operations East IV New Drug/Misbranded
Pingdingshan Tianjing Plant Albumen Co., Ltd. Center for Food Safety and Applied Nutrition (CFSAN) CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Jolca, S.A. Center for Food Safety and Applied Nutrition (CFSAN) Seafood HACCP/CGMP for Foods/Adulterated
Hunan Gagazui Food Co., Ltd. Center for Food Safety and Applied Nutrition (CFSAN) Low Acid Canned Food Regulation/Adulterated
Kevin R. Bender, M.D./DBC Research Corporation Center for Drug Evaluation and Research | CDER Clinical Investigator
Juquilita Mexican Imports LLC Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
ISPE Produce, Inc. Division of Southwest Imports Foreign Supplier Verification Program (FSVP)

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