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Altru Health System

FDA Regulatory Profile

Altru Health System has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 16, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 16, 2025Grand Forks, NDBiologicsVoluntary Action Indicated (VAI)3009905846
Jun 2, 2022Grand Forks, NDBiologicsNo Action Indicated (NAI)3009905846
Apr 7, 2016Grand Forks, NDBiologicsVoluntary Action Indicated (VAI)3009905846
May 6, 2014Grand Forks, NDBiologicsNo Action Indicated (NAI)3009905846

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3009905846Grand Forks, ND4May 16, 2025

FDA data resources

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