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 |
|---|---|---|---|---|---|---|---|
| Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs | Center for Devices and Radiological Health | Medical Device/Misbranded |
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| Korean Food, Inc. | Division of Human and Animal Food Operations West III | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Misbranded | |||||
| Hi-Pro Feeds, LLC | Division of Human and Animal Food Operations West III | CGMP/Medicated Feeds/Adulterated |
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| Future Diagnostics Solutions B.V. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| www.dashpct.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | |||||
| P.T. Sankei Medical Industries | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Spectrum Medical Ltd | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" | CGMP/QSR/Medical Devices/Adulterated | |||||
| Cardinal Health | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||||
| Zen Enterprises LLC | Center for Drug Evaluation and Research | CDER | Failure to Register and List | |||||
| Dr Sankunni’s Ayurvedic Research Foundation Private Ltd. | Center for Drug Evaluation and Research | CDER | Failure to Register and List |