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 |
---|---|---|---|---|---|---|---|
Guangdong Kemei Pharmaceutical Technology Co. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
Wholly Liquid Nutritional Supplements LLC | Office of Human and Animal Food Operations East – Division 1 | New Drug/Misbranded | |||||
Propaganda E-Liquid LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Vape Daugz LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Westside Vapor / Vapor Station | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Guangzhou Shiruoni Cosmetics Co., Ltd | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||||
Sarita's Tortilla Factory, Inc | Office of Human and Animal Food Operations West Division 3 | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
The Famous Lartigue Seafood | Office of Human and Animal Food Operations-East 5 | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
Maquiladora Miniara SA de CV | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | |||||
Global Medical Production Co Ltd | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |