FDA 483 - Del Medical, Inc. - March 19, 2021

Del Medical, Inc. in Bloomingdale, IL, an X-Ray Medical Device Manufacturer, was inspected by the FDA from February 18 to March 19, 2021. The inspection revealed significant deficiencies in their quality system, particularly concerning complaint handling, nonconforming product control, rework procedures, and supplier management. Several observations were repeats from a previous 2018 inspection, indicating persistent issues.