FDA Inspection 946552 — Allendale Investigational Review Board
The FDA completed an inspection of Allendale Investigational Review Board on September 24, 2015 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 24, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Old Lyme, CT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |