FDA 483 - BioLife Plasma Services L.P. - February 06, 2019

An FDA inspection of BioLife Plasma Services L.P. in Mt. Juliet, TN, a plasma center, revealed deficiencies in their standard operating procedures for determining donor eligibility. Specifically, the firm failed to adequately define criteria for medical conditions and did not obtain necessary information from physicians, resulting in a donor with a deferrable condition being allowed to donate multiple times. This indicates a significant lapse in donor screening protocols.