FDA 483 - Altru Health System - May 16, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 5e7e497f-21ac-495e-a24f-c10672fac931