FDA 483 - Dignitana, Inc. - November 05, 2024

Dignitana, Inc. in Dallas, TX, a specification developer of Class II medical devices, received a Form FDA 483 for failing to adequately establish corrective and preventive action (CAPA) procedures. The firm did not properly analyze and investigate numerous complaints regarding power cord damage and coolant leaks, nor did it assess the impact of design changes on devices already distributed to customers. This indicates a significant deficiency in their quality system's ability to address product nonconformities and ensure device safety post-distribution.