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ALZA UPGRADING DURAGESIC MANUFACTURING COMPLIANCE

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Executive Summary

ALZA UPGRADING DURAGESIC MANUFACTURING COMPLIANCE in response to a July 27 warning letter from FDA's San Francisco District Office, The letter directs Alza to "review all aspects of the Duragesic manufacturing and distribution procedures to insure that all records contain accurate and reliable data, and reflect that Alza is in full, control of the manufacturing processes necessary to produce safe and effective drugs." The warning letter followed an April 29 inspection of an Alza manufacturing facility in Vacaville, Calif.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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