FDA inspection
SALUDA MEDICAL PTY. LTD.: FDA inspection ending May 16, 2025
FDA inspection 1269838 · Voluntary Action Indicated (VAI) · Macquarie Park
Key facts
| Inspection ID | 1269838 |
|---|---|
| Firm | SALUDA MEDICAL PTY. LTD. |
| FEI number | 3021836309 |
| Address | 5 Eden Park Dr |
| City | Macquarie Park |
| Country | Australia |
| Fiscal year | 2025 |
| Inspection end date | May 16, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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