FDA 483 - Cardio Medical Products - November 05, 2019

An FDA inspection of Cardio Medical Products in Rockaway, NJ, revealed 10 observations related to significant deficiencies in their quality system. The firm lacked adequately established procedures for critical areas such as complaint handling, corrective and preventive actions, design control, management review, vendor qualification, training, document control, and Medical Device Reporting. These findings indicate a broad failure to implement and maintain a compliant quality system for medical device manufacturing.