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CLOSEOUT LETTER

Shanghai Apolo Medical Technology Co., Ltd. Jun 26, 2014

Shanghai Apolo Medical Technology Co., Ltd. - Close Out Letter 6/26/14


Shanghai Apolo Medical Technology Co., Ltd.

  

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

Public Health Service
 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

JUN 26, 2014


VIA UNITED PARCEL SERVICE


Peter Chiu
Owner/General Manager
Shanghai Apolo Medical Technology Co., Ltd.
3/F, Building A, No. 388
Yindu Road, Xuhui District
Shanghai 200231
China


Dear Mr. Chiu:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #268897, dated February 23, 2012. 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/

Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health