483
BioLife Plasma Services L.P.FDA 483 - BioLife Plasma Services L.P. - December 15, 2025
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An FDA inspection of BioLife Plasma Services L.P. in Orem, UT, a plasma center, revealed two significant observations. The firm failed to maintain equipment, specifically a blood sample refrigerator, according to manufacturer recommendations for preventive maintenance. Additionally, written standard operating procedures for donor screening did not fully incorporate manufacturer instructions for operating certain devices.
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