FDA Inspection
Staten Island University Hospital IRBStaten Island University Hospital IRB – FDA Inspection, Apr 3, 2009
Record Details
This FDA Inspection record concerns Staten Island University Hospital IRB, with an inspection on April 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 3, 2009
- Product Type
- Devices
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ID · fa32d05c-3f2a-4d21-bcc6-8431465affb1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 573578
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.108(c)Members present for review
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.20Exculpatory language, waiving of rights
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Staten Island University Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2010 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Staten Island University Hospital IRB
- FDA Inspection 668448 - 2010-05-25
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