# FDA 483 - CSL Behring (Australia) Pty Ltd - March 08, 2024

Source: https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/e85da09f-016a-4786-90d3-bb6ad18323ec

> FDA 483 for CSL Behring (Australia) Pty Ltd on March 08, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring (Australia) Pty Ltd
- Inspection Date: 2024-03-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CSL Behring (Australia) Pty Ltd was inspected regarding its drug substance manufacturing, revealing significant issues across multiple areas. The firm failed to control mold in manufacturing areas, released a drug substance batch with a major process deviation based on an inadequate risk assessment, and exhibited deficiencies in laboratory data management and written procedures. These observations indicate a lack of adequate control and oversight in critical manufacturing and quality control processes.

## Related Documents

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- [483 - 2022-03-08](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/68fb9b70-ae94-4dba-89c9-ad1c5a1ccf00)

## Related Officers

- [Lei Zhang](https://www.keypedia.com/people/lei-zhang/4cb14112-7090-4e62-b308-a1bc41cd6fcf)
- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)
- [Arnold Y. Seo](https://www.keypedia.com/people/arnold-y-seo/cd46b69c-c718-4aa1-96ad-10c064d01919)

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

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