483
BioLife Plasma Services L.P.FDA 483 - BioLife Plasma Services L.P. - November 22, 2024
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Record Details
An FDA inspection of BioLife Plasma Services L.P. in Arlington, TX, a plasmapheresis center, revealed a significant failure to maintain donor, quality control, and general records. The inspection found issues with labeling QC vials with open/expiration dates and obtaining proper donor consent due to equipment malfunction. These deficiencies indicate a lack of adherence to established procedures for critical record-keeping.
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ID · 2ca736de-9feb-40e6-a108-058389a55904