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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Jilin Shulan Synthetic Pharmaceutical Co., Ltd. - Close Out Letter 5/31/12

  

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 of International Drug Quality
10903 New Hampshire Avenue
Building #51, Room 4216
Silver Spring, MD 20993
TELEPHONE: (301) 796-5362
FAX: (301) 847-8742


May 31,2012

Mr. Li DaQain, President
Jilin Shulan Synthetic Pharmaceutical Co., Ltd.
No. 2066 Peoples Main Road
Shulan City, Jilin Province
People's Republic of China (PRC) 132600

Reference: FEI 3003091092

Dear Mr. Li:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-10-005, dated May 13, 2010. Based on our evaluation, it appears that you have addressed the violation(s) 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/

Francis Godwin
Acting Branch Chief
Intentional Compliance Branch