FDA 483 - Product Design and Development Corp. - January 24, 2025

Product Design and Development Corp. in Ellisville, MO, was inspected by the FDA, revealing significant deficiencies in their medical device manufacturing processes. Observations included the failure to apply unique device identifiers (UDI) to medical device labels and packaging, inadequate maintenance of device history records, and a lack of documented personnel training for critical assembly tasks. These issues indicate a need for improved quality system controls, with some observations being repeats from previous inspections.