FDA inspection
Ellipse A/S: FDA inspection ending Sep 18, 2015
FDA inspection 944713 · Official Action Indicated (OAI) · Horsholm
Key facts
| Inspection ID | 944713 |
|---|---|
| Firm | Ellipse A/S |
| FEI number | 3005112495 |
| Address | Agern Alle 11 |
| City | Horsholm |
| Country | Denmark |
| Fiscal year | 2015 |
| Inspection end date | Sep 18, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Radiation Control and Health Safety Act |
| 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