# FDA 483 - Aus Systems Pty Ltd - May 04, 2023

Source: https://www.keypedia.com/records/483/aus-systems-pty-ltd/281bb930-da9d-44f2-b698-4c9c7aa6d577

> FDA 483 for Aus Systems Pty Ltd on May 04, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aus Systems Pty Ltd
- Inspection Date: 2023-05-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Aus Systems Pty Ltd, a manufacturer in Allenby Gardens, South Australia, revealed three observations related to their quality system. Deficiencies included inadequate control over suppliers, insufficient documentation of corrective and preventive actions, and a lack of independence in quality audits. These issues indicate general weaknesses in the firm's quality management processes.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/aus-systems-pty-ltd/aa8c31e6-bfcf-44be-82ca-6d8478a171a3

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd