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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Letter Issue Date

Letters with Response or Closeout

Posted Date

Year

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject
11/07/2023	11/07/2023	Nic Nac Naturals, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/07/2023	10/30/2023	Dexterity Health, LLC DBA Zazzee Naturals	Center for Drug Evaluation and Research \| CDER	Finished Pharmaceuticals/Unapproved New Drug
11/07/2023	10/27/2023	Neurotris, Inc. dba A1 Engineering	Center for Devices and Radiological Health	Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
11/07/2023	09/01/2023	InnoMark, Inc.	Division of Human and Animal Food Operations West IV	CGMP/Dietary Supplement/Misbranded
11/07/2023	08/04/2023	Biorica International Corp.	Center for Food Safety and Applied Nutrition (CFSAN)	New Drug/Misbranded
11/07/2023	10/23/2023	ADM Animal Nutrition	Division of Human and Animal Food Operations East VI	CGMP/Animal Food/Adulterated
11/02/2023	11/02/2023	Wolfe Trading Company LLC d/b/a East Coast Vapors	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/02/2023	11/02/2023	8OHM1 d/b/a Digital Smoke	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/02/2023	11/02/2023	Velvet Vapor	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/02/2023	11/02/2023	Jams Vaporium	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded