# FDA 483 - CSL Plasma Inc - March 22, 2023

Source: https://www.keypedia.com/records/483/csl-plasma-inc/d0d28a4d-c691-4a20-8cfb-65734e1cfe1c

> FDA 483 for CSL Plasma Inc on March 22, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc
- Inspection Date: 2023-03-22
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: An FDA inspection of CSL Plasma, Inc. in Las Vegas, Nevada, revealed a critical deficiency in donor notification procedures. The firm failed to inform donors of reactive test results for relevant transfusion-transmitted infections, including positive HIV screening and confirmatory results, which led to donor deferral. This indicates a serious non-compliance with established protocols for unsuitable events management.

## Related Officers

- [Christopher M. Cox](https://www.keypedia.com/people/christopher-m-cox/15ce681f-a87d-4f98-a1ee-2ea574ce53c8)

Company: https://www.keypedia.com/companies/csl-plasma-inc/3b07f7d9-ffc4-4513-af12-edb0c75defc4

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df