FDA Inspection 943160 — San Jorge Children's Hospital IRB
The FDA completed an inspection of San Jorge Children's Hospital IRB on September 9, 2015 in San Juan, PR. 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 9, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Juan, PR (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7370 | 21 CFR 56.111(c) | Children as subjects |