Warning Letters

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.

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Letters with Response or Closeout

Posted Date

Year

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject
03/11/2022	03/10/2022	Soda Pharm	Center for Drug Evaluation and Research \| CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
03/10/2022	03/10/2022	Half Moon Mods LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
03/08/2022	03/08/2022	NXNW Vapor Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
03/08/2022	03/07/2022	Viraldine, LLC	Center for Drug Evaluation and Research \| CDER	Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19)
03/08/2022	02/11/2022	CardioQuip, LLC	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/PMA/Adulterated
03/08/2022	02/25/2022	ECBlend LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
03/08/2022	02/09/2022	Bea Lydecker’s Naturals, Inc.	Division of Human and Animal Food Operations West VI	Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
03/08/2022	01/07/2022	Wickimed Medical Equipment Manufacturing Co., Ltd.	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
03/08/2022	02/03/2022	Sergio Carranza dba MR CHESCOS	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
03/08/2022	02/07/2022	All Good Foods, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)