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 |
|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Integra LifeSciences Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Xoran Technologies, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | |||||
| Hologic, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | |||||
| By George Food Specialties Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Phillips Precision, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Reedhill Ventures LLC, d/b/a Vape On | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Ecig Charleston LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Evolution Pets LLC | Center for Veterinary Medicine | New Animal Drug/Adulterated | |||||
| HDFrenchies LLC dba Bully Baum | Center for Veterinary Medicine | New Animal Drug/Adulterated |