FDA Inspection 1204929 — Aus Systems Pty Ltd
The FDA completed an inspection of Aus Systems Pty Ltd on May 4, 2023 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Allenby Gardens (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3696 | 21 CFR 820.100(b) | Documentation |