FDA inspection
Englewood Hospital and Medical Center IRB: FDA inspection ending Nov 26, 2019
FDA inspection 1111224 · Voluntary Action Indicated (VAI) · Englewood, NJ
Key facts
| Inspection ID | 1111224 |
|---|---|
| Firm | Englewood Hospital and Medical Center IRB |
| FEI number | 2246539 |
| Address | 350 Engle St |
| City | Englewood |
| State | NJ |
| ZIP | 07631 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Nov 26, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data