U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  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
F1 Foods Inc. D/B/A Flavor First Foods Inc. Division of Human and Animal Food Operations East I Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Bret R. Rutherford, M.D. Center for Drug Evaluation and Research | CDER Clinical Investigator (Sponsor) 
New York State Psychiatric Institute IRB Center for Drug Evaluation and Research | CDER Institutional Review Board (IRB)
ReNovo, Inc. DBA Provision Device Reprocessing Solutions Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
Deqing Jiarou Daily Chemical Co., Ltd. Center for Drug Evaluation and Research | CDER CGMP/Finished Pharmaceuticals/Adulterated
Higley Industries, Inc. Division of Pharmaceutical Quality Operations III CGMP/Finished Pharmaceuticals/Adulterated
Ammonia Sport Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
TKTX Company Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
SeeNext Venture, Ltd. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Dermal Source, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded

SUBSCRIBE

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top