FDA 483 - Indiana University Health - June 12, 2019

An FDA inspection of Indiana University Health in Indianapolis, an establishment handling Blood Bank & HCT/P, revealed a significant issue with equipment maintenance. Specifically, cryogenic freezers used for storing human tissues were not maintained according to manufacturer's guidelines, indicating a lapse in established schedules for critical equipment. This suggests a moderate severity finding related to facility and equipment controls for HCT/Ps.