FDA 483 - Plaxtron Industrial (M) SDN. BHD. - August 15, 2024

Plaxtron Industrial (M) SDN. BHD. in Ipoh, Malaysia, was inspected by the FDA from August 12-15, 2024, and received six observations. The inspection revealed significant deficiencies in process validation, device history records, process monitoring, environmental controls, corrective and preventive actions, and equipment maintenance procedures. These issues indicate a systemic lack of adequate quality system controls for medical device manufacturing.