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 |
---|---|---|---|---|---|---|---|
Signature Biologics, LLC | Division of Biological Products Operations II | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
Fresenius Kabi AG | Division of Biological Products Operations I | CGMP Deviations | |||||
Luis Javier Pena-Hernandez, M.D., FCCP | Center for Drug Evaluation and Research | CDER | Clinical Investigator | |||||
Shot of Joy LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
Southern Tier Home Infusion, Inc. dba Pharmacy Innovations | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products | |||||
Oceanitan, Inc. | Division of Human and Animal Food Operations West V | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | |||||
Infinant Health, Inc formerly Evolve Biosystems Inc. | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Misbranded | |||||
The Vaping Dragon, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Caribbean Cloud Dot Com d/b/a Gorilla Vapes LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |