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