FDA 483 - Patheon Biologics Australia Pty Ltd - October 17, 2023

An FDA inspection of Patheon Biologics Australia Pty. Ltd. in Woolloongabba, Australia, a drug substance manufacturer, revealed significant deficiencies. Observations included a failure to establish the identity and suitability of incoming critical materials and components for drug substance manufacture. Additionally, the firm exhibited inadequate user access controls for electronic data acquisition systems, raising concerns about data integrity.