FDA Inspection 1157184 — Larkin Community Hospital IRB
The FDA completed an inspection of Larkin Community Hospital IRB on November 19, 2021 in South 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South Miami, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7372 | 21 CFR 56.115(b) | Access to records |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |