Company

United States

Indiana University IRB, Indianapolis, IN – FDA Inspections

Inspection records and compliance data for Indiana University IRB in Indianapolis, Indiana. 7 FDA inspections on record (1 OAI), last inspected August 08, 2025.

Company Profile

This profile covers Indiana University IRB based in Indianapolis, Indiana, United States.

FDA Inspection History

FDA inspections: 7
OAI: 1
VAI: 3
NAI: 2
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected September 17, 2009. Last inspected August 8, 2025.

Most cited issue areas

Members present for review2 inspections
Initial and continuing reviews1 inspection

FDA inspections (7)

Date	Result	FDA center(s)	Insp. #
August 8, 2025	Not classified	Biologics, Human Drugs, Medical Devices & Rad Health	1279195
February 14, 2020	VAI	Biologics, Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring	1117830
May 3, 2016	VAI	Medical Devices & Rad Health · Bioresearch Monitoring	971053
December 12, 2013	VAI	Human Drugs · Bioresearch Monitoring	858661
September 29, 2011	OAI	Human Drugs · Bioresearch Monitoring	748356
June 2, 2010	NAI	Biologics · Bioresearch Monitoring	664415
September 17, 2009	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	612861

FDA documents

Form 483s (1)

Form 483s · February 14, 2020

People (1)

Myra K. Casey

Person

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