FDA WARNING_LETTER - Moussa C. Mansour, MD - October 15, 2013

The FDA issued a Warning Letter to Dr. Moussa C. Mansour of Massachusetts General Hospital following an inspection from August 12 to October 15, 2013, concerning his role as a clinical investigator for studies involving the Watchman Left Atrial Appendage System (PROTECT-AF, CAP Registry, PREVAIL) and another investigational device. The inspection revealed serious violations of 21 CFR Part 812, Investigational Device Exemptions. Key violations included the failure to ensure investigations were conducted according to the investigational plan (21 CFR 812.100 and 812.110(b)). This involved unqualified or untrained staff performing critical assessments like neurological evaluations and trans-esophageal echocardiography (TEE), and the untimely reporting of Serious Adverse Events (SAEs) to the sponsor. Additionally, Dr. Mansour failed to maintain accurate, complete, and current records regarding correspondence with the IRB (21 CFR 812.140(a)(1)), evidenced by inaccurate reporting of subject deaths and adverse events. A further concern noted was the signing of neurological assessment worksheets completed by a study coordinator who was not employed at the hospital at the time of the subject visits, indicating a lack of proper oversight. The FDA deemed Dr. Mansour's submitted corrective action plans inadequate, citing insufficient detail on ensuring staff credentials, proper delegation, and verification of reported information. The letter requires Dr. Mansour to provide, within 15 working days, documentation of corrective and preventative actions, including revised SOPs, updated staff training records, and a plan to ensure timely SAE reporting and accurate IRB correspondence. Failure to comply could lead to regulatory action, including disqualification proceedings, emphasizing the critical need to protect human subjects and ensure data integrity.