FDA inspection
St Michael's Medical Center IRB: FDA inspection ending Feb 15, 2013
FDA inspection 821674 · Voluntary Action Indicated (VAI) · Newark, NJ
Key facts
| Inspection ID | 821674 |
|---|---|
| Firm | St Michael's Medical Center IRB |
| FEI number | 2243648 |
| Address | 111 Central Ave Floor 5 |
| City | Newark |
| State | NJ |
| ZIP | 07102 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Feb 15, 2013 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Drugs |
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