1061480
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Ann Arbor, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7652 | 21 CFR 56.113 | Reporting |