FDA Inspection 713978 — Allendale Investigational Review Board
The FDA completed an inspection of Allendale Investigational Review Board on February 23, 2011 in Old Lyme, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Old Lyme, CT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2966 | 21 CFR 812.66 | No IRB notification of significant risk determination |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |