FDA Inspection 680881 — North Broward Hospital District IRB
The FDA completed an inspection of North Broward Hospital District IRB on Sep 3, 2010 in Fort Lauderdale, 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Fort Lauderdale, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7340 | 21 CFR 56.108(a)(3) | Prompt reporting of changes |
| 7406 | 21 CFR 56.109(a) | Scope of reviews |