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  5. Hubei Weikang Protective Products Co., Ltd. - Close Out Letter 12/27/16
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CLOSEOUT LETTER

Hubei Weikang Protective Products Co., Ltd. Dec 27, 2016

Hubei Weikang Protective Products Co., Ltd. - Close Out Letter 12/27/16


Hubei Weikang Protective Products 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 

DEC 27, 2016

Xiangwu Yang
Chairman
Hubei Weikang Protective Products Co., Ltd.
GongQing ChuangYe Industrial Zone, Yewang Road
Xiantao City, Hubei1 433000
China

FEI: 3005090771

Dear Mr. Yang:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS #478843, dated October 2, 2015). Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,

/S/

M. Isabel Tejero del Rio, MD PhD
Deputy Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health

cc:

David Lennarz
U.S. Agent
Registrar Corp.
144 Research Drive
Hampton, UT 23666