# FDA 483 - CSL Behring AG - February 10, 2020

Source: https://www.globalkeysolutions.net/records/483/csl-behring-ag/b976a269-69e7-4b85-abb2-05252697f77b

> FDA 483 for CSL Behring AG on February 10, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Behring AG
- Inspection Date: 2020-02-10
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: CSL Behring AG in Bern, Switzerland, received a Form 483 with four observations related to its licensed biological manufacturing. The inspection revealed deficiencies in investigation records, procedures to prevent microbiological contamination, control of electronic forms, and calibration of instruments. These issues indicate potential risks to product quality and data integrity.

## Related Officers

- [Nammy Mathur](https://www.globalkeysolutions.net/people/nammy-mathur/399ba542-6aaf-4033-a4bb-63b515205627)
- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

Company: https://www.globalkeysolutions.net/companies/csl-behring-ag/e5513eac-b911-45b6-b707-dae3d0376210

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd