Altru Health Systems

FDA Regulatory Profile

Altru Health Systems has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 20, 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
Inspections9Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 20, 2025Grand Forks, NDBiologicsVoluntary Action Indicated (VAI)1774796
Aug 5, 2022Grand Forks, NDBiologicsNo Action Indicated (NAI)1774796
Aug 8, 2019Grand Forks, NDDrugsNo Action Indicated (NAI)1774796
May 31, 2019Grand Forks, NDBiologicsNo Action Indicated (NAI)1774796
Apr 7, 2016Grand Forks, NDBiologicsNo Action Indicated (NAI)1774796
May 6, 2014Grand Forks, NDBiologicsNo Action Indicated (NAI)1774796
Jun 26, 2012Grand Forks, NDBiologicsNo Action Indicated (NAI)1774796
Mar 29, 2011Grand Forks, NDDrugsNo Action Indicated (NAI)1774796
Dec 17, 2009Grand Forks, NDBiologicsVoluntary Action Indicated (VAI)1774796

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 1774796Grand Forks, ND9May 20, 2025

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