# FDA 483 - CSL Behring GmbH - April 18, 2024

Source: https://www.keypedia.com/records/483/csl-behring-gmbh/5e869e2f-39c4-427a-a730-ed3f66a5957b

> FDA 483 for CSL Behring GmbH on April 18, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring GmbH
- Inspection Date: 2024-04-18
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CSL Behring GmbH, a biologics and medical device manufacturer in Marburg, Germany, received one observation during an FDA inspection. The firm was cited for not adequately establishing procedures for corrective and preventive action (CAPA). Specifically, deficiencies were noted in the documentation and implementation of written procedures for complaint analysis and trend evaluation, indicating a significant quality system issue.

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- [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 - 2024-04-30](https://www.keypedia.com/records/483/csl-behring-gmbh/0bb3ff8a-a102-40f7-b84a-b9e4f0208242)
- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/csl-behring-gmbh/da7396b2-3718-41b6-8359-b772ae018755)

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

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