FDA 483 - LifeShare Blood Center - November 19, 2019

An FDA inspection of LifeShare Blood Center in Bossier City, LA, revealed significant deficiencies in quality control and record-keeping at its donor center. Observations included failures to maintain donor adverse reaction reports, conduct thorough investigations into discrepancies like temperature excursions, properly store critical supplies after a water leak, and adequately clean and maintain blood collection equipment. These issues indicate a lack of adherence to established procedures and regulatory requirements for blood product collection and handling.