FDA Inspection
Christus St. Patrick Hospital IRBFDA Inspection 666563 - Christus St. Patrick Hospital IRB - June 11, 2010
Record Details
This FDA Inspection record concerns Christus St. Patrick Hospital IRB, with an inspection on June 11, 2010, covering devices.
- Inspection Date
- June 11, 2010
- Product Type
- Devices
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ID · 431d4ffb-397d-4e0e-be23-ecd385575eda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666563
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Christus St. Patrick Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2009 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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