# FDA 483 - BioLife Plasma Services LP - December 16, 2021

Source: https://www.keypedia.com/records/483/biolife-plasma-services-lp/518cb17d-31c2-4b29-987b-6a15a3d4e644

> FDA 483 for BioLife Plasma Services LP on December 16, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioLife Plasma Services LP
- Inspection Date: 2021-12-16
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of BioLife Plasma Services LP in Jacksonville, FL, revealed two significant observations. The facility failed to ensure donor privacy during health history screenings and did not maintain sterile conditions during phlebotomy site preparation. These issues indicate potential risks to donor confidentiality and product sterility.

## Related Officers

- [Amanda B Vega](https://www.keypedia.com/people/amanda-b-vega/9629eae7-acd3-4d4a-b456-a9427b525efb)

Company: https://www.keypedia.com/companies/biolife-plasma-services-lp/e608bee4-f299-4780-891b-1561e2f6e89b

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6