FDA Inspection
Christus St. Patrick Hospital IRBFDA Inspection 570101 - Christus St. Patrick Hospital IRB - March 19, 2009
Record Details
This FDA Inspection record concerns Christus St. Patrick Hospital IRB, with an inspection on March 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 19, 2009
- Product Type
- Devices
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ID · eb8c708d-cbd6-4a87-b148-750569b55923
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 570101
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 56.111(a)(2)Risks to subjects reasonable
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Christus St. Patrick Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2010 | VAI | Bioresearch Monitoring |
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