FDA Inspection 1291014 — Wills Eye Hospital IRB
The FDA completed an inspection of Wills Eye Hospital IRB on October 17, 2025 in Philadelphia, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Philadelphia, PA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |