FDA 483 - BioLife Plasma Services L.P. - June 08, 2021

An FDA inspection of BioLife Plasma Services L.P. in Arlington, TX, revealed significant deficiencies in their handling of source plasma. The firm failed to properly relabel "Source Plasma Salvaged" units after temperature excursions and did not maintain adequate records for these affected units. Additionally, donor deferral records for communicable disease positive donors were found to be backdated, hindering traceability of critical safety steps.