483
BioLife Plasma Services LPBioLife Plasma Services LP – FDA 483
Record Details
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.
- Company
- BioLife Plasma Services LP
- Product type
- biologics
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ID · 348a496f-fa9b-49c7-ac40-2907c7f51530
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