FDA Inspection 1269838 — SALUDA MEDICAL PTY. LTD.
The FDA completed an inspection of SALUDA MEDICAL PTY. LTD. on May 16, 2025 in Macquarie Park. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Macquarie Park (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |