# FDA 483 - CSL Behring GmbH - April 30, 2024

Source: https://www.keypedia.com/records/483/csl-behring-gmbh/0bb3ff8a-a102-40f7-b84a-b9e4f0208242

> FDA 483 for CSL Behring GmbH on April 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring GmbH
- Inspection Date: 2024-04-30
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of CSL Behring GmbH in Marburg, Germany, identified significant deficiencies across its drug product manufacturing operations. Key issues include an inadequately designed aseptic process, insufficient quality oversight leading to questionable batch releases, and failures in preventing microbiological contamination. The firm also demonstrated shortcomings in environmental monitoring, visual inspection programs, cleaning procedures, and adherence to written procedures for deviation management and batch record completion.

## Related Documents

- [483 - 2018-05-17](https://www.keypedia.com/records/483/csl-behring-gmbh/e8c1c8f8-2bbb-4021-a093-576c7317ffce)
- [483 - 2022-03-04](https://www.keypedia.com/records/483/csl-behring-gmbh/45772e3f-dea9-45ad-b478-23cd419f7dbe)
- [483 - 2024-04-18](https://www.keypedia.com/records/483/csl-behring-gmbh/ca2ced1c-5c71-4740-af7b-1686b0a70fc5)
- [483 - 2024-04-18](https://www.keypedia.com/records/483/csl-behring-gmbh/5e869e2f-39c4-427a-a730-ed3f66a5957b)
- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/csl-behring-gmbh/da7396b2-3718-41b6-8359-b772ae018755)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/charles-y-kuo/36d44416-c980-4b33-b62e-ea0761a46a46)
- [Richard Ledwidge](https://www.keypedia.com/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.keypedia.com/companies/csl-behring-gmbh/21a38e53-2e5d-4c9e-a287-79597f091cc6

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