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, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 11, 2010
- Product Type
- Drugs
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ID · 41033ccb-1706-4db2-ae07-28ae2f5f777d
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
- Human Drugs
- 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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