FDA Inspection 630363 — The Medical Center IRB
The FDA completed an inspection of The Medical Center IRB on Nov 18, 2009 in Beaver, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 18, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Beaver, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |