FDA 483 - CND Global Technologies Inc. - November 15, 2019

CND Global Technologies Inc. in Cumberland, RI, was inspected and received a Form FDA-483 with 10 observations, indicating a severe lack of established procedures across nearly all critical aspects of their quality system for the ODI HD Dental Sensor. Key deficiencies include the absence of written procedures for design control, purchasing, MDRs, CAPA, acceptance activities, nonconforming product, labeling, device history records, and complaint handling. The firm is a manufacturer, relabeler, and repacker of medical devices.