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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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BioCheck Inc - Close out letter


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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay parkway
Alameda, CA 94502-7070
Telephone: 510/337-6700 


February 16, 2011

Jung-Shou Chen
President and CEO
BioCheck, Inc.
323 Vintage Park Drive
Foster City, California 94404

Dear Mr. Chen:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 7, 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 Jetter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Barbara J. Cassens
District Director
San Francisco District Office