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.

Filter by

Issuing Office

Letter Issue Date

Letters with Response or Closeout

Posted Date

Year

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject
02/21/2023	01/26/2023	Desert Defense, LLC	Center for Veterinary Medicine	Unapproved New Animal Drug Products
02/21/2023	01/19/2023	Sohgave LLC	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
02/16/2023	02/16/2023	Hastings Vapors LLC d/b/a Hastings Vapors	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/14/2023	01/30/2023	Lyons Magnus, LLC	Division of Human and Animal Food Operations West I	Low Acid Canned Food Regulation/Adulterated
02/14/2023	01/24/2023	American Cruise Lines	Division of Human and Animal Food Operations East V	Insanitary Conditions/Adulterated
02/14/2023	11/16/2022	Wintech Medipro LLC	Division of Medical Device and Radiological Health Operations West	CGMP/QSR/Medical Devices/PMA/Adulterated
02/14/2023	02/13/2023	Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated
02/14/2023	02/03/2023	Flavor Vapors, LLC/Mob Liquid Labs	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/14/2023	01/30/2023	Clean Cosmetics LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
02/09/2023	02/09/2023	Unlit Vapor Shoppe LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded