FDA 483 - BioLife Plasma Services L.P. - November 22, 2024

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.