FDA 483 - Harper University Hospital - July 01, 2025

Harper University Hospital in Detroit, a blood bank, was issued a Form 483 with four observations following an inspection. The firm failed to submit biological product deviation reports to CBER and did not consistently follow written standard operating procedures for processing blood components. Significant issues were noted regarding the inadequate standardization of equipment, specifically an irradiator, and a failure to thoroughly investigate unexplained discrepancies and non-conforming events related to blood product irradiation.