483
Innovis Health, LLCInnovis Health, LLC – FDA 483, Jun 11, 2025
Record Details
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
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