FDA Inspection 672654 — Coast IRB LLC
The FDA completed an inspection of Coast IRB LLC on Apr 29, 2009 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Colorado Springs, CO (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2966 | 21 CFR 812.66 | No IRB notification of significant risk determination |
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 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 |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7322 | 21 CFR 56.111 (a)(2) | Risks to subjects reasonable |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |