FDA Inspection 870691 — Brava, LLC
The FDA completed an inspection of Brava, LLC on March 14, 2014 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 14, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Miami, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14511 | 21 CFR 812.2(b) | Abbreviated requirements / non-significant risk study |
| 14521 | 21 CFR 812.36(e) | No IRB approval for treatment use |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 3000 | 21 CFR 812.140(b)(4)(v) | Sponsor records re QSR/GMP & non-significant risk studies |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |