FDA Inspection 1198493 — Ponce Medical School Foundation, Inc. IRB
The FDA completed an inspection of Ponce Medical School Foundation, Inc. IRB on February 24, 2023 in Ponce, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 24, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Ponce, PR (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7334 | 21 CFR 56.115(a)(5) | List of members |