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  5. Shanghai Shunlong Physical Therapy Equipment Co. - Close Out Letter 11/19/15
  1. Warning Letters

CLOSEOUT LETTER

Shanghai Shunlong Physical Therapy Equipment Co.


Shanghai Shunlong Physical Therapy Equipment Co.

  

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

NOV 19 2015
 

VIA UNITED PARCEL SERVICE

Xiuzhen Hsu
General Manager
Shanghai Shunlong Physical Therapy Equipment Co. Ltd.
No. 259 Jiugan Road
Songjiang District
201601 Shanghai, China

Dear Mr. Hsu:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (#288084, dated March 27, 2012). Based on our evaluation, it appears that you have addressed the violations contained in the 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