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 |
---|---|---|---|---|---|---|---|
SZ Vape LLC, d/b/a Vype Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Cue Health, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
|||||
Caribbean Cloud Dot Com d/b/a Gorilla Vapes of Philadelphia | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Augustine Temperature Management, LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||||
Global Cosmetics Company Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
APG SEVEN, INC | Division of Human and Animal Food Operations East IV | New Drug/Misbranded | |||||
Pingdingshan Tianjing Plant Albumen Co., Ltd. | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
Jolca, S.A. | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated | |||||
Kevin R. Bender, M.D./DBC Research Corporation | Center for Drug Evaluation and Research | CDER | Clinical Investigator | |||||
Juquilita Mexican Imports LLC | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |