# FDA 483 - BioLife Plasma Services LP - March 25, 2022

Source: https://www.keypedia.com/records/483/biolife-plasma-services-lp/e877a367-3ba8-4ccc-9925-984f1659e5bf

> FDA 483 for BioLife Plasma Services LP on March 25, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioLife Plasma Services LP
- Inspection Date: 2022-03-25
- Product Type: biologics
- Office Name: Denver District Office
- Summary: BioLife Plasma Services LP in Aurora, CO, was inspected from March 22-25, 2022, and received one observation. The firm failed to conduct a thorough investigation into a Unit Over Nomogram (UON) event caused by apheresis equipment machine failure. Specifically, the investigation did not include corrective actions addressing the identified root cause.

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/biolife-plasma-services-lp/28b77936-d449-4bd5-a6bf-b81fc6582d2f

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face