# FDA 483 - Altru Health Systems - May 20, 2025

Source: https://www.keypedia.com/records/483/altru-health-systems/ee856e3e-93b7-42a7-b77a-4fbedfbfb8fa

> FDA 483 for Altru Health Systems on May 20, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Altru Health Systems
- Inspection Date: 2025-05-20
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

Company: https://www.keypedia.com/companies/altru-health-systems/ab9ebaa9-7b91-482d-abd1-7ad48b5a6c43

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d