FDA Inspection
St Elizabeth Medical Center IRBSt Elizabeth Medical Center IRB – FDA Inspection, Jun 29, 2009
Record Details
This FDA Inspection record concerns St Elizabeth Medical Center IRB, with an inspection on June 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 29, 2009
- Product Type
- Devices
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ID · 856e634e-4f3e-43ac-a375-4bc521635b26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596627
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of St Elizabeth Medical Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St Elizabeth Medical Center IRB
- FDA Inspection 919660 - 2015-03-19
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