FDA inspection
Ellex Medical Pty Ltd.: FDA inspection ending May 11, 2018
FDA inspection 1052407 · Voluntary Action Indicated (VAI) · Mawson Lakes
Key facts
| Inspection ID | 1052407 |
|---|---|
| Firm | Ellex Medical Pty Ltd. |
| FEI number | 3002806902 |
| Address | 3-4 Second Ave |
| City | Mawson Lakes |
| Country | Australia |
| Fiscal year | 2018 |
| Inspection end date | May 11, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
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