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

Source: https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/a278fabf-22b4-42d0-b3a4-c8f51c3655a6

> 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: Baltimore District Office
- Summary: During an inspection conducted from February 28 to March 8, 2022, the U.S. Food and Drug Administration (FDA) issued a Form 483 to CSL Behring Australia Proprietary Ltd., a manufacturer of plasma derivatives located in Broadmeadows, Victoria. This report highlights significant concerns regarding the company's compliance with manufacturing and quality control standards.

The inspection revealed three primary observations. Firstly, laboratory records lacked complete data from necessary tests and examinations, and there was insufficient quality oversight for critical data, impacting the assurance of data integrity for products like Privigen. Procedures for comprehensive data review were absent. Secondly, procedures to prevent microbiological contamination in sterile drug products were found to be inadequate. Disinfectant efficacy studies failed to meet established acceptance criteria for key manufacturing surfaces and microorganisms, indicating that routine sanitization methods were not sufficiently qualified for their intended use. Finally, the firm's analytical methods for detecting bacterial contamination in sterile drug product batches were deemed insufficient, as critical qualification steps were not adequately described, thereby questioning the reliability of contamination detection.

These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, indicate potential deviations from current Good Manufacturing Practices. CSL Behring is required to respond to these findings, outlining implemented or planned corrective actions to address the identified deficiencies and ensure product quality and safety.

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

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

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa