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

Source: https://www.keypedia.com/records/483/innovis-health-llc/ce4905bc-8646-42e2-a50e-c43f28a3569c

> FDA 483 for Innovis Health, LLC on June 11, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Innovis Health, LLC
- Inspection Date: 2025-06-11
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.keypedia.com/companies/innovis-health-llc/b21f68eb-f66b-48e7-baf2-83defedf93c9

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