FDA Inspection 976080 — Nova Southeastern University IRB #1
The FDA completed an inspection of Nova Southeastern University IRB #1 on Jun 16, 2016 in Davie, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Davie, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |