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 |
---|---|---|---|---|---|---|---|
Iotech International, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||||
Yogi's Vape Hays | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Yogi's Vape | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Euphrates Foods, LLC dba Labeeb Alani Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
Ivermectin24h.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Misbranded Drugs to United States Consumers Over the Internet | |||||
Sabine S. Hazan, M.D. | Center for Drug Evaluation and Research | CDER | Investigational Review Board (IRB) | |||||
Fella Group LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
Okami Brand LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
NeuroField, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
Craving Vapor Industries, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |