FDA Inspection 1269751 — Altru Health System

Altru Health System — FEI 3009905846

The FDA completed an inspection of Altru Health System on May 16, 2025 in Grand Forks, 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
May 16, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Grand Forks, ND (United States)

Citations

IDCFRDescription
1808121 CFR 630.10(e)(1)Medical Assessment Factors
922521 CFR 606.171Biological product deviation report

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.