FDA 483 - Coapt LLC - December 11, 2019

An FDA inspection of Coapt LLC, a medical device manufacturer in Chicago, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding the verification and validation of CAPA effectiveness. Additionally, procedures for receiving, reviewing, and evaluating complaints were found to be inadequate, with issues in MDR reportability evaluations and complaint documentation.