FDA 483 - Uscom Limited - May 29, 2025

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.