FDA Inspection 681452 — Nova Southeastern University IRB #1
The FDA completed an inspection of Nova Southeastern University IRB #1 on Sep 9, 2010 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
- Sep 9, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Davie, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7406 | 21 CFR 56.109(a) | Scope of reviews |