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CLOSEOUT LETTER

GRI Medical & Electronic Technology Co., Ltd Oct 09, 2014

GRI Medical & Electronic Technology Co., Ltd - Close Out Letter 10/9/14


GRI Medical & Electronic Technology Co., 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 09 2014


Mr. Martin D. Paugh
Executive Vice President
GRI Medical & Electronic Technology Co., Ltd
1805 Honggao Road
Jiaxing, Zhejiang,
314031, China

Dear Mr. Paugh:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter [#394146 dated May 01, 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