FDA Inspection 1196560 — N.Y.S. Psychiatric Institute IRB
The FDA completed an inspection of N.Y.S. Psychiatric Institute IRB on February 2, 2023 in New York, NY. 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
- February 2, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |