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.
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 | |||||
Deqing Jiarou Daily Chemical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
Bret R. Rutherford, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
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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 | |||||
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 | |||||
Sky Bank Media, LLC dba Painless Tattoo Cream Co. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |