FDA 483 - Cochlear Americas Inc. - February 22, 2018

An FDA inspection of Cochlear Americas Inc. in Centennial, CO, acting as a sponsor for an investigational study, revealed significant non-compliance. The firm failed to adhere to investigational plans, regulatory requirements, and IRB/FDA approval conditions, particularly concerning informed consent processes. Additionally, issues were noted with the accuracy and completeness of adverse device effect reports and the overall inadequacy of monitoring activities for the clinical study.