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

Source: https://www.keypedia.com/records/483/csl-behring-gmbh/80a99cd4-5d44-4a32-8ec9-ec050ae78f78

> 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 Medical Device and Radiological Health Operations
- Summary: An FDA inspection of CSL Behring GmbH in Marburg, Germany, from April 15-18, 2024, revealed significant deficiencies in the firm's quality system. The primary concern was the inadequate establishment and implementation of procedures for corrective and preventive actions, specifically regarding the analysis and trending of complaint data. This indicates a failure to properly manage and address 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-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4