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 |
---|---|---|---|---|---|---|---|
Green Pharmaceutical Co. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
Lex Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
Osmosis, LLC | Division of Human and Animal Food Operations East IV | Unapproved New Drugs/Misbranded | |||||
Route 66 Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Great Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Reckitt/Mead Johnson Nutrition | HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) | CGMP/Quality Control/Adulterated/Infant Formula | |||||
Perrigo Wisconsin, LLC | HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) | CGMP/Quality Control/Adulterated/Infant Formula | |||||
ByHeart, Inc. | HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB) | CGMP/Quality Control/Adulterated/Infant Formula | |||||
Tesla BioHealing, Inc. | Division of Medical Device and Radiological Health Operations East | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) | |||||
Cosmobeauti Laboratories & Manufacturing Inc. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |