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Saint Luke's Health System IRB

FDA Regulatory Profile

Saint Luke's Health System IRB has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 12, 2025 · NAI

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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
Inspections2Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 12, 2025Kansas City, MODevicesNo Action Indicated (NAI)1929747
Aug 6, 2009Kansas City, MODrugsNo Action Indicated (NAI)1929747

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 1929747Kansas City, MO2Jun 12, 2025

FDA data resources

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