Company
United StatesExempla Healthcare, IRB, Denver, CO – FDA Inspections
Inspection records and compliance data for Exempla Healthcare, IRB in Denver, Colorado. 2 FDA inspections on record, last inspected January 27, 2014.
Company Profile
This profile covers Exempla Healthcare, IRB based in Denver, Colorado, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 21, 2009. Last inspected January 27, 2014.
Most cited issue areas
- Changes in approved research1 inspection
- Initial and continuing reviews1 inspection
- Minutes of IRB meetings1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 27, 2014 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 864809 |
| September 21, 2009 | VAI | Human Drugs · Bioresearch Monitoring | 617080 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Exempla Healthcare, IRB
FEI Number
3001451998
Address
1835 Franklin St Mulle, Mullen Building, Room 219, Denver, Colorado 80218, United States
Country
United States
ID: f265f45c-ff9a-4f21-b7b9-42fffd5ee435