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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Xian Libang Pharmaceutical Co., Ltd. Close out Letter 7/7/11

  

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 4221
Silver Spring, MD 20993
TELEPHONE: (301) 796-3334
FAX: (301) 847-8742 


7 July 2011


Mr. WuChao
Plant Director
Xian Libang Pharmaceutical Co., Ltd.
No. 42 Fengshang Weiyang District, Xian
Shaanxi,
China


Reference: FEI3003657863


Dear Mr. Chao:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-10-01, dated January 28, 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/
Maan Abduldayem
Compliance Officer
International Compliance Branch