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
02/15/2022	02/03/2022	ECI Pharmaceuticals, LLC	Center for Drug Evaluation and Research \| CDER	Failure to Register and List
02/15/2022	02/02/2022	Indiana Chem-Port	Center for Drug Evaluation and Research \| CDER	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
02/15/2022	02/03/2022	GreenSmartLiving, Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/15/2022	02/04/2022	Victory Vapor Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/15/2022	02/04/2022	Crystal Clear Supplements	Center for Drug Evaluation and Research \| CDER	Unapproved New Drugs/Misbranded
02/15/2022	02/04/2022	Vapor Solutions and Labs, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/15/2022	10/29/2021	Marquis Worldwide Specialty, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
02/15/2022	02/01/2022	Jay Shree Hanuman, Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/15/2022	02/04/2022	Walker Trading Company, Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
02/15/2022	02/04/2022	Richard J. Obiso, PhD dba Avila Herbals, LLC	Center for Drug Evaluation and Research \| CDER	Clinical Investigator