FDA 483 - BioLife Plasma Services L.P.

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.