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  5. Jiangsu Province Jianerkang Medical Dressing Co., Ltd. - Close Out Letter 11/6/14
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CLOSEOUT LETTER

Jiangsu Province Jianerkang Medical Dressing Co., Ltd.


Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4235
Silver Spring, MD 20993

TELEPHONE: (301) 796-4839
                 FAX: (301) 847-8742

 

November 6, 2014


Mr. Chen Guoping
President
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
Zhixi Town, Jintan City, Jiangsu, 213251
P.R. China
Phone: 86 5192441878


Reference: FEI 3006403682


Dear Mr. Guoping:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-12-02 issued on July 20, 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,

/S/

Rafael Arroyo
Division of International Drug Quality