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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Yunnan Hande Bio-Tech. Co. Ltd. - Close Out Letter 10/25/11


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

Public Health Service
Food and Drug Administration

Office of Manufacturing and Product Quality
Division of International Drug Quality
10903 New Hampshire Avenue
Building #51, Room 4237
Silver Spring, MD 20993
TELEPHONE: (301) 796-4839
FAX: (301) 847-8742

October 25, 2011

Ms. Huang Lei
Director and Chairman
Yunnan Hande Bio-Tech, Co., Ltd
No.3 Platform, Jinding Tech Zone
Kunming, 650033, P.R. China

Reference: FEI3002808537

Dear Ms. Lei:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-11-01, dated October 15,2010. 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.



Rafael Arroyo
Compliance Officer
Division International Compliance Branch