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

Source: https://www.keypedia.com/records/483/csl-behring-gmbh/ecaf163d-80cc-41ac-a92d-a3824fe5fe2b

> 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: Office of Inspections and Investigations
- Summary: CSL Behring GmbH, a biologics and medical device manufacturer in Marburg, Germany, was inspected by the FDA. The inspection revealed deficiencies in the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and implement written procedures for the analysis and trend evaluation of complaints to identify existing and potential quality problems.

## Related Documents

- [EIR - 2022-03-04](https://www.keypedia.com/records/eir/csl-behring-gmbh/94c73acf-8284-406a-994b-222868545616)
- [483 - 2018-05-17](https://www.keypedia.com/records/483/csl-behring-gmbh/ff548397-dc14-4b14-8664-389d7c724d1c)
- [483 - 2024-04-18](https://www.keypedia.com/records/483/csl-behring-gmbh/5e869e2f-39c4-427a-a730-ed3f66a5957b)
- [483 - 2022-03-04](https://www.keypedia.com/records/483/csl-behring-gmbh/45772e3f-dea9-45ad-b478-23cd419f7dbe)
- [483 - 2018-05-17](https://www.keypedia.com/records/483/csl-behring-gmbh/e8c1c8f8-2bbb-4021-a093-576c7317ffce)

## 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/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8