Company
United StatesRoper St. Francis Hospital IRB, Charleston, SC – FDA Inspections
Inspection records and compliance data for Roper St. Francis Hospital IRB in Charleston, South Carolina. 2 FDA inspections on record, last inspected September 16, 2016.
Company Profile
This profile covers Roper St. Francis Hospital IRB based in Charleston, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 13, 2008. Last inspected September 16, 2016.
Most cited issue areas
- Initial and continuing reviews1 inspection
- Prompt reporting of noncompliance1 inspection
- Prompt reporting of unanticipated problems1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 986251 |
| November 13, 2008 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 547470 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Roper St. Francis Hospital IRB
FEI Number
1000111054
Address
316 Calhoun St, Charleston, South Carolina 29401, United States
Country
United States
ID: 1cfad4ee-289a-43a9-b95d-d25bb5a1d3a6