483
Patheon Biologics Australia Pty LtdFDA 483 - Patheon Biologics Australia Pty Ltd - October 17, 2023
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Record Details
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.
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ID · 72aa249c-8f41-4da3-8622-8fea898e7c0c