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CLOSEOUT LETTER

ARC Medical Supplies (Beijing) Co., Ltd. May 08, 2015

ARC Medical Supplies (Beijing) Co., Ltd. - Close Out Letter 5/8/15


ARC Medical Supplies (Beijing) 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

 

MAY 8, 2015

 

Hongzhang Wang
President and General Manager
ARC Medical Supplies Beijing Co., Ltd.
II Xingyuan Street
Miyun Industrial Park
101500 Beijing
China


Dear Mr. Wang:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #167872, March 28, 2011 . 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/

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