FDA inspection
Somerset Medical Center IRB: FDA inspection ending Sep 30, 2016
FDA inspection 989881 · Official Action Indicated (OAI) · Somerville, NJ
Key facts
| Inspection ID | 989881 |
|---|---|
| Firm | Somerset Medical Center IRB |
| FEI number | 3012733828 |
| Address | 110 Rehill Ave |
| City | Somerville |
| State | NJ |
| ZIP | 08876 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Sep 30, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Bioresearch Monitoring |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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