FDA inspection
Euroimmun US, Inc.: FDA inspection ending Sep 6, 2019
FDA inspection 1123894 · Voluntary Action Indicated (VAI) · Mountain Lakes, NJ
Key facts
| Inspection ID | 1123894 |
|---|---|
| Firm | Euroimmun US, Inc. |
| FEI number | 3007118747 |
| Address | 1 Bloomfield Ave |
| City | Mountain Lakes |
| State | NJ |
| ZIP | 07046-1429 |
| Fiscal year | 2019 |
| Inspection end date | Sep 6, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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