746974
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 7, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Browns Mills, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |