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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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AMPAC Fine Chemicals, Inc. Close out Letter 4/25/11

  

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

Public Health Service
Food and Drug Administration
 

San Francisco District Pacific Region

1431 Harbor Bay Parkway 

Alameda, CA 94502-7070
Telephone: 510-337-6700

FAX: 510-337-6701 


April 25, 2011


Mr. Aslam A. Malik, Ph.D., President

AMPAC Fine Chemicals, Inc.

Highway 50 and Hazel Avenue

Rancho Cordova, CA 95670


Dear Dr. Malik:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated June 25, 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/
Barbara Cassens
District Director

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