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 |
|---|---|---|---|---|---|---|---|
| Fuller Industries Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Edge Biologicals Inc. | Division of Medical Device and Radiological Health Operations Central | CGMP/QSR/Medical Devices/Adulterated | |||||
| Eden’s Answers, Inc. | Division of Human and Animal Food Operations East V | CGMP/Dietary Supplement/Adulterated |
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| Wisetrade Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Ocalsa Transport & Logistics, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Bella Mia Foods, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Centaur Pharmaceuticals Private Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Outset Medical, Inc. | Center for Devices and Radiological Health | Premarket Approval/Adulterated | |||||
| The National Tobacco Alliance, Inc. d/b/a KC Smoke & Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Vapor Sense League City | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |