# FDA 483 - BioLife Plasma Services L.P. - Unknown Date

Source: https://www.keypedia.com/records/483/biolife-plasma-services-lp/348a496f-fa9b-49c7-ac40-2907c7f51530

> FDA 483 for BioLife Plasma Services L.P. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BioLife Plasma Services L.P.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BioLife Plasma Services L.P. in Bakersfield, CA, a source plasma collection facility, was cited for failing to consistently provide donors with all screening and confirmatory test results for relevant transfusion-transmitted infections (RTTIs). The firm did not notify donors of all test results, including those from subsequent donations, for HBsAg and HCV, despite implementing a process change in June 2023. This indicates a deficiency in their donor notification procedures.

## Related Officers

- [Michelle D. Gutierrez](https://www.keypedia.com/people/michelle-d-gutierrez/b6117afc-1a01-41b0-a0e6-6aeb33935968)

Company: https://www.keypedia.com/companies/biolife-plasma-services-lp/c6c157bd-8027-4dda-89ae-ac8178e55477

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd