FDA 483 - DiaPharma Group Inc - April 29, 2022

DiaPharma Group Inc. in West Chester, OH, was inspected by the FDA from April 26-29, 2022. The inspection revealed a significant issue with the firm's design change procedures, specifically the lack of validation for design changes. This deficiency led to a packaging design change for a Factor X Kit being implemented and shipped without proper validation, despite being initiated due to customer complaints about broken vials.