Indiana University IRB

FDA Regulatory Profile

Indiana University IRB has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 8, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections7Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 8, 2025Indianapolis, INDrugsNo Action Indicated (NAI)1823570
Feb 14, 2020Indianapolis, INBiologicsVoluntary Action Indicated (VAI)1823570
May 3, 2016Indianapolis, INDevicesVoluntary Action Indicated (VAI)1823570
Dec 12, 2013Indianapolis, INDrugsVoluntary Action Indicated (VAI)1823570
Sep 29, 2011Indianapolis, INDrugsOfficial Action Indicated (OAI)1823570
Jun 2, 2010Indianapolis, INBiologicsNo Action Indicated (NAI)1823570
Sep 17, 2009Indianapolis, INDevicesNo Action Indicated (NAI)1823570

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 1823570Indianapolis, IN7Aug 8, 2025

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