FDA Inspection 1272398 — Innovis Health, LLC D.B.A. Essentia Health
The FDA completed an inspection of Innovis Health, LLC D.B.A. Essentia Health on Jun 11, 2025 in Fargo, ND. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 11, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fargo, ND (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 9225 | 21 CFR 606.171 | Biological product deviation report |