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
05/26/2023	05/25/2023	Mean Street Vapor LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/25/2023	05/25/2023	Breeze Smoke, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/25/2023	05/25/2023	Shenzhen Innokin Technology Co., Ltd.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/23/2023	05/18/2023	Champaklal Maganlal Homeo Pharmacy Private Limited	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
05/23/2023	04/25/2023	Krishiv Foods, LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
05/23/2023	05/12/2023	H.E.A.L. Marketplace	Division of Human and Animal Food Operations East III	New Drug/Misbranded
05/23/2023	03/24/2023	Sure-Biochem Laboratories, LLC	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
05/18/2023	05/18/2023	Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/16/2023	04/04/2023	Sea-Long Medical Systems, LLC	Division of Medical Device and Radiological Health Operations West	CGMP/QSR/Medical Devices/Adulterated
05/16/2023	04/27/2023	EarthLab, Inc., dba Wise Woman Herbals	Division of Human and Animal Food Operations West VI	Unapproved New Drugs/Misbranded

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