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 |
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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 | |||||
Nobles Medical Technology II, Inc. | Center for Devices and Radiological Health | Investigational Review Board (IRB) | |||||
Spirochaete Research Labs, LLC aka Scitus Laboratory Products | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
Human Microbes | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) |
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Better Vapes LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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FLVRS US, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Vaping Studio Inc | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Colgin, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated |