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CLOSEOUT LETTER

COTRONIC Technology Limited


COTRONIC Technology Limited

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

Via United Parcel Service

FEB 14, 2017
 

Kwong Ping Wong
Director
Cotronic Technology Limited
Room 1407, Worldwide Industrial Centre
43 Shan Mei Street
Fotan, Shatin
Hong Kong
People's Republic of China

Dear Mr. Wong:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS #481155, dated December 1, 2015). 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.

Sincerely,
/S/
Matthew Krueger, M.S.E.
Acting Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health