FDA Inspection 583294 — The Queen's Medical Center IRB
The FDA completed an inspection of The Queen's Medical Center IRB on May 6, 2009 in Honolulu, HI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Honolulu, HI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |