Company
United StatesDuke Clinical Research Institute, Durham, NC – FDA Inspections
Inspection records and compliance data for Duke Clinical Research Institute in Durham, North Carolina. 4 FDA inspections on record, last inspected January 17, 2019.
Company Profile
This profile covers Duke Clinical Research Institute based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected August 24, 2012. Last inspected January 17, 2019.
Most cited issue areas
- Ensuring compliance with plan and protocol1 inspection
- General responsibilities of sponsors1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 17, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1081929 |
| November 4, 2015 | VAI | Human Drugs · Bioresearch Monitoring | 953435 |
| September 19, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 848158 |
| August 24, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 796022 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Richard L. Rauck, M.D.
Margaret R. Pardee Memorial Hospital IRB
Gorbec Pharmaceutical Services Inc.
Aultman Health Foundation HRRB
Memorial Health Service Research Council
Richard Berkowitz
Sligh, Teresa S. MD
Banyan International Corp
SUNY Downstate Health Sciences University IRB & Privacy Board
VisionAid, Inc.
Company Information
Name
Duke Clinical Research Institute
FEI Number
3006738414
Address
300 W Morgan St Ste 800, Durham, North Carolina 27701, United States
Country
United States
ID: b4576dbb-823b-42fb-83a4-9bc304e2adbb