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

An FDA inspection of Mission Hospitals Transfusion Service in Asheville, NC, revealed that the firm failed to consistently follow its written standard operating procedures for processing and distributing blood and blood components. Specifically, procedures for neonatal transfusion aliquot preparation were not adhered to, resulting in improper handling and dispensing of an RBC neonatal aliquot. This indicates a significant lapse in procedural compliance within the hospital's transfusion service.