Micro-X Ltd. – FDA 483, Jan 15, 2026

Micro-X Ltd. in Tonsley, South Australia, a medical device manufacturer, was cited for significant deficiencies in its quality system. The firm failed to adequately establish and implement procedures for design changes, leading to unverified field corrections. Additionally, the inspection revealed inadequate procedures for receiving, reviewing, and evaluating customer complaints, resulting in numerous potential complaints not being properly documented or assessed for Medical Device Reporting.