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CLOSEOUT LETTER

Sure On Industries Ltd. Oct 21, 2014

Sure On Industries Ltd. - Close Out Letter 10/21/14


Sure On Industries Ltd.

  

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

 

OCT 21, 2014


Cheng-Yen Wen
Vice President
Sure On Industries Ltd.
Bldg. 2, Zhu Fo Ling
168 Industrial Area, Tang Xia
Dong Guan City
China


Dear Mr. Wen:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #319538, dated January 23, 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.

 

Sincerely yours,

/S/

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