FDA Inspection 1111224 — Englewood Hospital and Medical Center IRB
The FDA completed an inspection of Englewood Hospital and Medical Center IRB on November 26, 2019 in Englewood, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 26, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Englewood, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |