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

Source: https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/ac8f83cc-46f0-4a4b-80a2-30e074bdfe83

> 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: Baltimore District Office
- Summary: During an FDA inspection conducted from February 29 to March 8, 2024, CSL Behring (Australia) Pty Ltd, a drug substance manufacturer, received a Form FDA 483 listing significant observations. The inspection revealed several areas requiring attention to ensure compliance with quality standards.

Key issues included a lack of adequate control over mold in manufacturing areas, with numerous mold recoveries in classified rooms that were not effectively trended or addressed by appropriate corrective and preventive actions. The facility's mold action limits were deemed insufficient to trigger necessary responses.

Furthermore, a drug substance batch with a major process deviation	extemdash specifically, multiple interruptions during the viral filtration step	extemdash was released based on an inadequate risk assessment. Laboratory data management also demonstrated deficiencies, including a failure to perform second-person verification for critical data entries into the Laboratory Information Management System (LIMS). This led to delayed detection of specification errors and calculation discrepancies, some dating back several years.

Finally, numerous written procedures and documents were found to lack sufficient detail or clarity. Examples include incomplete reagent preparation instructions, inadequate automatic integration parameters for HPLC leading to manual interventions, and ambiguous instructions for assigning release status in StarLIMS, which resulted in miscategorized raw material batches. The company also lacked specific procedures for handling leaks in processing tanks to assess microbial risks.

CSL Behring is required to respond to these observations with comprehensive corrective and preventive actions to address the identified deficiencies and ensure compliance with regulatory expectations for drug manufacturing.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/7b2f4dac-7728-4213-addb-6a988a425a1c)
- [483 - 2022-03-08](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/68fb9b70-ae94-4dba-89c9-ad1c5a1ccf00)
- [483 - 2022-03-08](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/a278fabf-22b4-42d0-b3a4-c8f51c3655a6)
- [483 - 2024-03-08](https://www.keypedia.com/records/483/csl-behring-australia-pty-ltd/e85da09f-016a-4786-90d3-bb6ad18323ec)

## Related Officers

- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)
- [Lei Zhang](https://www.keypedia.com/people/lei-zhang/4cb14112-7090-4e62-b308-a1bc41cd6fcf)
- [Drug Discovery and Biotech Executive](https://www.keypedia.com/people/lloyd-d-payne/8b98c38a-4fbe-465d-bb0a-689bcc6db702)
- [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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa