FDA Inspection
Roper St. Francis Hospital IRBRoper St. Francis Hospital IRB – FDA Inspection, Nov 13, 2008
Record Details
This FDA Inspection record concerns Roper St. Francis Hospital IRB, with an inspection on November 13, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 13, 2008
- Product Type
- Devices
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ID · 357b2bab-92c4-4971-a592-ed49f260ce2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547470
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
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Other FDA inspections of Roper St. Francis Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Roper St. Francis Hospital IRB
- FDA Inspection 986251 - 2016-09-16
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