FDA 483 - Innovis Health, LLC - June 11, 2025

An FDA inspection of Innovis Health, LLC d.b.a. Essentia Health's blood bank in Fargo, ND, revealed two significant observations. The firm failed to submit a biological product deviation report for an RBC unit issued without proper checks. Additionally, the inspection found failures in maintaining quality control and general records, including undocumented deviations and a lack of documented calculations for reconstituted blood products.