FDA 483 - BioLife Plasma Services L.P. - October 17, 2019

An FDA inspection of BioLife Plasma Services L.P. in Grandville, MI, a plasmapheresis collection center, revealed a significant issue with equipment maintenance. The firm failed to perform regularly scheduled calibration and preventative maintenance on a plasmapheresis machine used for source plasma collections. This indicates a lapse in adhering to standard operating procedures for critical equipment.