FDA 483 - BioLife Plasma Services, LP

An FDA inspection of BioLife Plasma Services, LP in Oklahoma City, Oklahoma, from February 11-13, 2020, revealed a critical lapse in donor screening procedures. The firm failed to consistently perform required serologic tests for syphilis and serum protein electrophoresis on samples collected on the day of initial physical examination or plasmapheresis for first-time donors. This resulted in the collection of approximately 289 units of Source Plasma from unsuitable donors, which were not subsequently identified or quarantined.