FDA 483 - Micro-X Ltd. - May 23, 2024

Micro-X Ltd., a manufacturer of Micro-X Rover Mobile X-ray Systems, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality system procedures, including failures to report device corrections, establish adequate design change controls, validate manufacturing processes, implement effective CAPA procedures, and properly evaluate complaints for MDR reporting. These issues indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.