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
10/06/2023	10/06/2023	D&A Distribution, LLC d/b/a Strictly E-cig	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/05/2023	10/05/2023	Safa Goods, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/05/2023	10/05/2023	Be Smokeless LLC d/b/a Southwest Smokeless	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/05/2023	10/05/2023	Cloud House Vape	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/05/2023	10/05/2023	Rochester Smoke Shop Inc	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/03/2023	08/04/2023	Day Light Nutrition	Division of Human and Animal Food Operations West II	New Drug/Misbranded
09/29/2023	09/20/2023	Luis Javier Pena-Hernandez, M.D., FCCP	Center for Drug Evaluation and Research \| CDER	Clinical Investigator
09/29/2023	09/25/2023	Shot of Joy LLC	Center for Drug Evaluation and Research \| CDER	Unapproved New Drugs/Misbranded
09/29/2023	09/18/2023	Signature Biologics, LLC	Division of Biological Products Operations II	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
09/29/2023	09/14/2023	Fresenius Kabi AG	Division of Biological Products Operations I	CGMP Deviations