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 |
|---|---|---|---|---|---|---|---|
| Bret R. Rutherford, M.D. | Center for Drug Evaluation and Research | CDER | Clinical Investigator (Sponsor) |
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| Wagco Distribution, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Jiangsu Shenli Medical Production Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||||
| Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
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| Sol-Millennium Medical, Inc. | Division of Medical Device and Radiological Health Operations Central | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
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| Furst-McNess Company | Division of Human and Animal Food Operations West I | CGMP/Medicated Feeds/Adulterated | |||||
| Skull Smash LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | |||||
| My Vapor Den DBA Nu Age Smoke & Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Exactech, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Boehringer Ingelheim Animal Health USA | Center for Veterinary Medicine | False & Misleading Claims/Misbranded |