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 |
---|---|---|---|---|---|---|---|
HealthMEDS Inc. | Center for Drug Evaluation and Research | CDER | Failure to permit access to or copying of records | |||||
Notarika, S.A. de C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
GuangZhou YouXing Cosmetic Co., Ltd | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/IRB | |||||
Missouri Analytical Laboratories Inc | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
Kim Nhung Marketplace Inc | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
Liquid Nics LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Imperial Vapors LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Local Legends Distribution LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Perfect Vape LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |