Company
United StatesDuke University Health System IRB, Durham, NC – FDA Inspections
Inspection records and compliance data for Duke University Health System IRB in Durham, North Carolina. 5 FDA inspections on record, last inspected September 11, 2025.
Company Profile
This profile covers Duke University Health System IRB based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 1, 2010. Last inspected September 11, 2025.
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 11, 2025 | Not classified | Biologics, Human Drugs, Medical Devices & Rad Health | 1283176 |
| March 1, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1083586 |
| September 1, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 987166 |
| February 4, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 711315 |
| July 1, 2010 | NAI | Biologics · Bioresearch Monitoring | 674756 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Sterigenics US, LLC
Henry Ford Health System Institutional Review Board
Yale University Institutional Review Board
NCH - Healthcare System
Jackson Hospital and Clinic, Inc. IRB
Baton Rouge General Medical Center IRB
Allendale IRB
IRB for the Baylor College of Medicine
Cape Cod Healthcare IRB
Minneapolis VA Health Care System IRB
Company Information
Name
Duke University Health System IRB
FEI Number
1045114
Address
2424 Erwin Rd Ste 405, Durham, North Carolina 27705, United States
Country
United States
ID: 5491ca09-c784-4a57-a20f-2d16f824c560