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  5. Andersen America, Inc. - 01/28/2014
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Andersen America, Inc.

Andersen America, Inc.

United States

Issuing Office:

United States


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

 Food and Drug Administration
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502

Telephone: (510) 337-6886
FAX: (510) 337-6703


January 28, 2014

Mr. Nobumitsu Kobayashi, President
Andersen America, Inc.
30703 San Clemente St.
Hayward, CA 94544

Dear Mr. Kobayashi:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated October 22, 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.




Kathleen M. Lewis, J.D.
District Director
San Francisco District Office

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