# FDA 483 - CSL Plasma Inc. - February 12, 2020

Source: https://www.keypedia.com/records/483/csl-plasma-inc/a92d05f7-e7e3-4426-a672-adebfe4d1228

> FDA 483 for CSL Plasma Inc. on February 12, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSL Plasma Inc.
- Inspection Date: 2020-02-12
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: CSL Plasma, Inc. in New Hope, MN, was inspected for its Source Plasma operations, revealing significant issues with donor eligibility determination. The firm failed to clarify donor responses or obtain omitted information within 24 hours for multiple donors screened with incorrect gender-specific health history questionnaires or incomplete screenings. Additionally, the company failed to submit required biological product deviation reports for these affected units.

## Related Officers

- [investigator](https://www.keypedia.com/people/melissa-d-kalik/5b707db5-e068-4c08-8063-fe89e2f10ece)

Company: https://www.keypedia.com/companies/csl-plasma-inc/6f254d09-eb38-4e0e-9c0b-dba42812d3b7

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d