FDA Inspection
Mercy Hospital Medical Center IRBMercy Hospital Medical Center IRB – FDA Inspection, Jun 13, 2013
Record Details
This FDA Inspection record concerns Mercy Hospital Medical Center IRB, with an inspection on June 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 13, 2013
- Product Type
- Devices
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ID · 29f14ff3-fba5-45a8-be61-67ece4216511
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 830565
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
10- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(b)Information given to subjects
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.109(c)(1)Exception for informed consent; minimal risk study
- 21 CFR 812.66No IRB notification of significant risk determination
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