AUS SYSTEMS PTY LTD. — FDA Facility Profile
AUS SYSTEMS PTY LTD. is an FDA-registered facility (FEI 3005921952) located in ALLENBY GARDENS South Australia, AU. RegDataLab tracks 4 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 25, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (4 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 25, 2026 | Voluntary Action Indicated (VAI) | Records of validation of processes and necessary actions not maintained (ISO 13485:2016 Clause 7.5.6) Lack of Written MDR Procedures (21 CFR 803.17) |
| May 4, 2023 | Voluntary Action Indicated (VAI) | Quality audits - auditor independence (21 CFR 820.22) Supplier oversight (21 CFR 820.50(a)(2)) Documentation (21 CFR 820.100(b)) |
| Aug 20, 2015 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Documentation (21 CFR 820.80(e)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 2 more |
| Sep 12, 2012 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.80(e)) |
Facility details
- Company
- Aus Systems Pty Ltd
- Location
- ALLENBY GARDENS South Australia (AU)
- Source
- device