# FDA 483 - CSL Behring (Australia) Pty Ltd - March 08, 2022

Source: https://www.globalkeysolutions.net/records/483/csl-behring-australia-pty-ltd/68fb9b70-ae94-4dba-89c9-ad1c5a1ccf00

> FDA 483 for CSL Behring (Australia) Pty Ltd on March 08, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring (Australia) Pty Ltd
- Inspection Date: 2022-03-08
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of CSL Behring Australia Proprietary Ltd in Broadmeadows revealed significant deficiencies in laboratory controls, sterile manufacturing, and product testing. Observations included incomplete laboratory records with inadequate data review, failed disinfectant efficacy studies, and deficient analytical methods for detecting microorganisms in drug products. These findings indicate a lack of assurance in data integrity and product sterility.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Eileen A. Liu](https://www.globalkeysolutions.net/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.globalkeysolutions.net/companies/csl-behring-australia-pty-ltd/85c32ac7-6cc3-45f8-a596-8d36e2671f59

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321