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 |
---|---|---|---|---|---|---|---|
La Crosse Smokes 4 Less 1 Inc. d/b/a SMOKES 4 LESS | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
American Legends Eliquid | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Bespoke Apothecary LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||||
Ecig Vapor Juice Store | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Med Pen Concepts, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | |||||
Vapeoholic LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
GN Tobacco Sweden AB d/b/a White Fox USA | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Muscle Sports Products, LLC | Office of Human and Animal Food Operations East – Division 1 | Unapproved New Drugs/Misbranded | |||||
Zhejiang Tianyu Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
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System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |