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