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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
LA VAPOR INC. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Choo's Enterprises Ltd Center for Food Safety and Applied Nutrition (CFSAN) Acidified Foods/Emergency Permit Control/Adulterated
Optikem International Inc. Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated
New Mexico Lions Sight Conservation Foundation, Inc. dba New Mexico Lions Eye Bank Division of Biological Products Operations II Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
AG Essence, Inc. Center for Devices and Radiological Health Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
PepsiCo, Inc. Division of Human and Animal Food Operations East VI CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Fuyang Fuchunjiang Canned Food Co., Ltd. Center for Food Safety and Applied Nutrition (CFSAN) Low Acid Canned Food Regulation/Adulterated
Natural Ginger, Corp/Jonaus Corp Division of Human and Animal Food Operations East IV New Drug/Misbranded
Sakhon Wattana Thang Chue Hah Center for Food Safety and Applied Nutrition (CFSAN) Seafood HACCP/CGMP for Foods/Adulterated
Laboratorio Magnachem International Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

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