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  5. Apotex Inc. - 05/02/2014
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Apotex Inc.

Apotex Inc.

United States

Issuing Office:

United States


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 International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4212
Silver Spring, MD 20993

TELEPHONE: (301) 796-3916
                 FAX: (301) 847-8742


May 2, 2014

Dr. Jeremy B. Desai, MBA
President & Chief Operating Officer
Apotex Inc.
150 Signet Drive
Toronto, ON, Canada M9L 1T9

Reference: FEI 3001617666 and 302906944

Dear Dr. Desai:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-13-09 and date February 21, 2013. 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.




Maan Abduldayem
Compliance Officer
Division of International Drug Quality 

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