# FDA 483 - CSL Behring (Australia) Pty Ltd - Unknown Date

Source: https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/7b2f4dac-7728-4213-addb-6a988a425a1c

> FDA 483 for CSL Behring (Australia) Pty Ltd on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring (Australia) Pty Ltd
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of CSL Behring Australia Proprietary Ltd, a manufacturer of plasma derivatives, revealed significant deficiencies in their manufacturing process controls. The firm failed to establish adequate procedures for monitoring the output of manufacturing processes, specifically regarding the assessment and monitoring of internal in-process control specifications for their U.S. licensed IVIG product. Additionally, the company did not submit required Biological Product Deviation Reports for numerous complaints of cracked or broken vials.

## Related Documents

- [483 - 2022-03-08](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/68fb9b70-ae94-4dba-89c9-ad1c5a1ccf00)
- [483 - 2024-03-08](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/e85da09f-016a-4786-90d3-bb6ad18323ec)

## Related Officers

- [Gena Arcy, CSO](https://www.keypedia.com/people/gena-arcy-cso/5e73742f-22df-4750-82a8-430f86192916)
- [Yonggang Wang, Ph.D., Biologist](https://www.keypedia.com/people/yonggang-wang-phd-biologist/cc515757-20e0-487e-aa24-86c131b722c0)
- [Scott Ballard, CSO, National Expert](https://www.keypedia.com/people/scott-ballard-cso-national-expert/eddbe750-64dc-49e7-8b2b-5125ab381424)

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