U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Vincent Medical (Dong Guan) Manufacturing Co., Ltd. - 03/31/2015
  1. Warning Letters


Vincent Medical (Dong Guan) Manufacturing Co., Ltd.

Vincent Medical (Dong Guan) Manufacturing Co., Ltd.

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

 Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993



March 31, 2015

Mr. Vincent Man Shing Choi
Managing Director
Vincent Medical (Dong Guan)
Manufacturing Co., Ltd.
45-46 ShaBu Industrial Zone
Qiaolong District, Tangxia
523730 Dong Guan, Guangdong
P.R. China

Dear Mr. Choi:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 408035, dated September 3, 2013. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.



Carl Fischer, Ph.D.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health

Back to Top