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

Source: https://www.globalkeysolutions.net/records/483/patheon-biologics-australia-pty-ltd/72aa249c-8f41-4da3-8622-8fea898e7c0c

> FDA 483 for Patheon Biologics Australia Pty Ltd on October 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics Australia Pty Ltd
- Inspection Date: 2023-10-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Yun Wu](https://www.globalkeysolutions.net/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.globalkeysolutions.net/companies/patheon-biologics-australia-pty-ltd/ede6b641-a0a7-4b0b-918b-f09c3b1d060b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd