FDA Inspection 570101 — Christus St. Patrick Hospital IRB
The FDA completed an inspection of Christus St. Patrick Hospital IRB on Mar 19, 2009 in Lake Charles, LA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lake Charles, LA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7322 | 21 CFR 56.111 (a)(2) | Risks to subjects reasonable |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |