University of Virginia IRB for Health Sciences Research, Charlottesville, VA – FDA Inspections

Inspection records and compliance data for University of Virginia IRB for Health Sciences Research in Charlottesville, Virginia. 4 FDA inspections on record, last inspected May 31, 2024.

Company Profile

This profile covers University of Virginia IRB for Health Sciences Research based in Charlottesville, Virginia, United States.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 1
NAI: 3
Form 483s: 0
Warning letters: 0

First inspected May 4, 2010. Last inspected May 31, 2024.

Most cited issue areas

At least five members with varying backgrounds1 inspection
Circumstances of obtaining consent1 inspection
IRB approvals/disapprovals - general1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
May 31, 2024	NAI	Biologics, Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring	1240614
April 26, 2018	NAI	Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring	1052472
April 19, 2013	VAI	Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring	829777
May 4, 2010	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	660068

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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