483
Innovis Health, LLCFDA 483 - Innovis Health, LLC - June 11, 2025
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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.
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ID · ce4905bc-8646-42e2-a50e-c43f28a3569c