FDA 483 - Altru Health Systems - May 20, 2025

An FDA inspection of Altru Health Systems, a hospital blood bank in Grand Forks, ND, revealed a significant issue with equipment standardization. Specifically, a platelet testing system's validation was found to be deficient, including uninvestigated unexpected results and a validation plan approved after testing. This led to the distribution and transfusion of numerous platelet products tested with the unvalidated instrument.