# FDA 483 - Baxter Healthcare Pty Ltd - July 05, 2022

Source: https://www.keypedia.com/records/483/baxter-healthcare-pty-ltd/2d56a6e8-65c1-43eb-b1da-a640222f7b44

> FDA 483 for Baxter Healthcare Pty Ltd on July 05, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Healthcare Pty Ltd
- Inspection Date: 2022-07-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Baxter Healthcare Pty Ltd, a manufacturer of sterile human drugs in Old Toongabbie, Australia, was cited for failing to follow procedures designed to prevent microbiological contamination. The inspection revealed significant issues with documentation regarding HEPA filter repairs, including conflicting records and a lack of investigation into these discrepancies. These deficiencies impact sterile drug products, including specific injections, intended for the US market.

## Related Officers

- [Senior CSO, Investigator](https://www.keypedia.com/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.keypedia.com/companies/baxter-healthcare-pty-ltd/a37e00b9-5cbd-4f45-922b-0f352f015507

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