FDA Inspection 1210833 — Louisiana State University Health Sciences Center IRB
The FDA completed an inspection of Louisiana State University Health Sciences Center IRB on Jul 26, 2023 in New Orleans, 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
- Jul 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- New Orleans, LA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7651 | 21 CFR 56.113 | Statement of reasons |