FDA Inspection 708648 — Christus Spohn Hospital Corpus Christi - Memorial Campus
The FDA completed an inspection of Christus Spohn Hospital Corpus Christi - Memorial Campus on Feb 4, 2011 in Corpus Christi, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 4, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Corpus Christi, TX (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7328 | 21 CFR 56.111(b) | Vulnerable subject safeguards |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7372 | 21 CFR 56.115(b) | Access to records |