FDA Inspection
The Medical Center IRBThe Medical Center IRB – FDA Inspection, Nov 18, 2009
Record Details
This FDA Inspection record concerns The Medical Center IRB, with an inspection on November 18, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- The Medical Center IRB
- Inspection Date
- November 18, 2009
- Product Type
- Biologics
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ID · 5c177ecb-0b23-4b3c-98a7-5bf7c592d591
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 630363
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
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