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|
|Wise Spice Catering Company||Division of Human and Animal Food Operations East IV||CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated|
|NuGeneration Technologies LLC||Division of Pharmaceutical Quality Operations IV||CGMP/Finished Pharmaceuticals/Adulterated|
|Robert J. Hayashi, M.D./Washington University School of Medicine, Department of Pediatrics||Center for Drug Evaluation and Research | CDER||Bioresearch Monitoring Program/IRB|
|Nara Company Ltd.||Center for Food Safety and Applied Nutrition (CFSAN)||Seafood HACCP/CGMP for Foods/Adulterated|
|Vanlaw Food Products, Inc||Division of Human and Animal Food Operations West V||Food Labeling/Misbranded|
|Todos Medical Ltd aka Todos Medical USA Inc||Center for Food Safety and Applied Nutrition (CFSAN)||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
|Tyrone L. McCall, M.D./Cornea Associates of Texas||Center for Drug Evaluation and Research | CDER||Clinical Investigator (Sponsor)
|Stuff N Puffs 101, LLC d/b/a Stuff-N-Puffs||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Mariscos Bahia, Inc.||Division of Human and Animal Food Operations West V||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions|
|Herbal Vitality, Inc.||Division of Human and Animal Food Operations West IV||Unapproved New Drugs/Misbranded