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

Source: https://www.globalkeysolutions.net/records/483/csl-behring-gmbh/ca2ced1c-5c71-4740-af7b-1686b0a70fc5

> 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 Regulatory Affairs
- Summary: From April 15 to April 18, 2024, the U.S. Food and Drug Administration (FDA) conducted an inspection of CSL Behring GmbH, a biologics and medical device manufacturer located in Marburg, Germany. The inspection resulted in a Form FDA 483 identifying significant deficiencies in the facility"s quality management systems. The primary violation cited involves the failure to establish and maintain adequate procedures for corrective and preventive actions. Specifically, the FDA investigator found that the company did not fully document justifications for whether further actions were needed after analyzing trends in consumer complaints. Furthermore, CSL Behring lacked written procedures for certain data evaluation processes and failed to include evaluations of alert limit deviations in their trend analysis records. These issues suggest that potential quality problems may not be sufficiently identified or addressed. Under the regulatory framework for biologics and medical device manufacturing, the company is responsible for maintaining a robust quality system. While the 483 does not represent a final agency determination, CSL Behring is required to respond to these observations by outlining corrective measures they have taken or plan to implement to ensure compliance with quality standards.

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- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/csl-behring-gmbh/da7396b2-3718-41b6-8359-b772ae018755)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64