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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Teva Pharmaceutical Industries - Close Out Letter 9/9/11


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 4219
Silver Spring, MD 20993

TELEPHONE: (301) 796-3194
FAX: (301) 847-8742

9 September 2011

Mr. Shlomo Yanai
President and CEO
Teva Pharmaceutical Industries Ltd.
Petach-Tikva 5 Basel Street
PO Box Box 3190
Petach Tikva 4931, Israel

Dear Mr. Shlomo:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-11-08 dated January 31, 2011. 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.



Brian L. Belz
Compliance Officer
Division of International Drug Quality