483
BioLife Plasma Services L.P.BioLife Plasma Services L.P. – FDA 483, Jun 25, 2026
Record Details
An FDA inspection of BioLife Plasma Services L.P. in Thornton, CO, revealed two significant observations. The firm failed to adequately qualify equipment used in source plasma collection, including apheresis machines and donor screening monitors. Additionally, the donor screening station was found to be inadequately designed, preventing donors from maintaining proper seated posture during blood pressure measurements, which could impact the accuracy of donor eligibility determinations.
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ID · fd353072-18f5-4946-9a86-177692eeb616
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