FDA Inspection 1323412 — Aus Systems Pty Ltd
The FDA completed an inspection of Aus Systems Pty Ltd on Jun 25, 2026 in Allenby Gardens. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Allenby Gardens (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |