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  5. Tianjin Hanaco Xingda Medical Co., Ltd. - 08/11/2017
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Tianjin Hanaco Xingda Medical Co., Ltd.

Tianjin Hanaco Xingda Medical Co., Ltd.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo1
Silver Spring, MD 20993 


10903 New Hampshire Avenue
Silver Spring, MD 20993 


August 11, 2017

Via United Parcel Service

Chen Zhifa
General Manager
Tianjin Hanaco Xingda Medical Co., Ltd.
No. 4, Qijing Road
Dongli Economic Development Zone
300300 Tianjin

Dear Mr. Chen Zhifa

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #365678. 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.

Ronald L. Swann, MS
Acting Director
Division of International Compliance
Office of Compliance
Center for Devices and Radiological Health

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