# FDA 483 - Uscom Limited - May 29, 2025

Source: https://www.keypedia.com/records/483/uscom-limited/f28ff6f9-1a92-4a48-b3c6-89d19059259b

> FDA 483 for Uscom Limited on May 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Uscom Limited
- Inspection Date: 2025-05-29
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Uscom Limited, a manufacturer of Class II medical devices in Sydney, Australia, revealed significant deficiencies in their quality management system. The firm failed to adequately document rework and reevaluation activities, including not following non-conformance procedures for out-of-calibration devices and leaving non-conformance reports open for extended periods. Additionally, the inspection found that quality audits were not conducted by qualified individuals as per the firm's own procedures.

## Related Officers

- [Marvin A. Marenco](https://www.keypedia.com/people/marvin-a-marenco/b4638545-ba1f-4b1c-940f-7c18c5f436ed)

Company: https://www.keypedia.com/companies/uscom-limited/5011f184-e8df-4949-a185-3461350f0eb2

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8