# FDA 483 - BioLife Plasma Services LP - January 31, 2020

Source: https://www.keypedia.com/records/483/biolife-plasma-services-lp/f12d8b52-55bd-444a-ac7a-25b35c74dd55

> FDA 483 for BioLife Plasma Services LP on January 31, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioLife Plasma Services LP
- Inspection Date: 2020-01-31
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Biolife Plasma Services L.P. in Springfield, MO, revealed a critical failure to ensure plasmapheresis donors met eligibility criteria. Specifically, a donor with a history of male-to-male sexual contact falsely answered health history questions and was not deferred even after this information was disclosed. This indicates a significant lapse in donor screening and eligibility protocols at the facility.

## Related Officers

- [Supervisory](https://www.keypedia.com/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)

Company: https://www.keypedia.com/companies/biolife-plasma-services-lp/de50bb4e-cbf6-4a9e-868a-ebbe95d35212

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8