FDA 483 - BioLife Plasma Services L.P. - December 15, 2025

An FDA inspection of BioLife Plasma Services L.P. in Orem, UT, a plasma center, identified two significant observations. The firm failed to maintain equipment, specifically a blood sample refrigerator, according to manufacturer's preventive maintenance recommendations. Additionally, written standard operating procedures for donor screening did not fully incorporate manufacturer's instructions for operating certain devices.