# FDA 483 - CSL Behring GmbH - March 04, 2022

Source: https://www.keypedia.com/records/483/csl-behring-gmbh/45772e3f-dea9-45ad-b478-23cd419f7dbe

> FDA 483 for CSL Behring GmbH on March 04, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring GmbH
- Inspection Date: 2022-03-04
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of CSL Behring GmbH in Marburg, Germany, a licensed biological drug manufacturer, revealed significant deficiencies. The firm failed to adequately investigate product discrepancies and complaints, including mold and yeast contamination, and lacked sufficient rationale for not investigating retention samples. Furthermore, the facility exhibited poor maintenance with recurring insect infestations, and procedures to prevent microbiological contamination of sterile drug products were found to be insufficient, along with inadequate cleaning validations and issues with vial crimping.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
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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