# FDA 483 - Baxter Laboratories Pty. Ltd. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/baxter-laboratories-pty-ltd/8881a98f-54c9-49d0-841f-08ffed5bc55a

> FDA 483 for Baxter Laboratories Pty. Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Laboratories Pty. Ltd.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.globalkeysolutions.net/companies/baxter-laboratories-pty-ltd/4f07afb7-4f57-465e-a0fd-14dc07c2211c

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1