FDA 483 - Mission Hospitals Transfusion Service - May 15, 2025

Mission Hospitals Transfusion Service in Asheville, NC, was inspected by the FDA, revealing a significant procedural non-compliance. The firm failed to consistently follow its written standard operating procedures for the processing and distribution of blood and blood components, specifically concerning neonatal transfusion aliquot preparation and timing. This indicates a lapse in adherence to established protocols for critical patient care.