FDA 483 - Baxter Laboratories Pty. Ltd.

Baxter Laboratories Pty. Ltd. in Boronia, Australia, was cited for five significant violations during an FDA inspection. The firm demonstrated severe data integrity vulnerabilities with uncontrolled computer systems and raw data worksheets, and failed to maintain equipment qualification and facility sanitation. Additionally, the Quality Unit did not adhere to product quality review procedures and neglected annual visual examinations of reserve samples.