FDA 483 - Altru Health System - May 16, 2025

Altru Health System in Grand Forks, ND, was inspected by the FDA, revealing two significant observations. The firm failed to adequately assess donor medical history by omitting critical questions regarding sexual contact, potentially increasing the risk of transfusion-transmitted infections. Additionally, the facility failed to submit a required biological product deviation report after collecting and distributing blood products from a donor whose screening was incomplete due to incorrect gender registration.