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 |
---|---|---|---|---|---|---|---|
Soda Pharm | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||||
Half Moon Mods LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
NXNW Vapor Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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Viraldine, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) | |||||
CardioQuip, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated | |||||
ECBlend LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Bea Lydecker’s Naturals, Inc. | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products | |||||
Wickimed Medical Equipment Manufacturing Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
Sergio Carranza dba MR CHESCOS | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
All Good Foods, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |