FDA 483 - Boston Scientific Corporation - November 16, 2018

An FDA inspection of Boston Scientific Corporation in Maple Grove, MN, identified significant issues in the management of an investigational clinical study. The firm's PMA Clinical Study Report records were found to be inaccurate and incomplete, with numerous unreported safety events and protocol deviations. Furthermore, proper monitoring of clinical study sites was not ensured, leading to unaddressed non-compliances and a failure to secure investigator compliance.