Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ALZA UPGRADING DURAGESIC MANUFACTURING COMPLIANCE

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.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS024929

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel