FDA 483 - Sasidhar P. Kilaru, M.D. - November 23, 2021

Sasidhar P. Kilaru, M.D., a clinical investigator in Cincinnati, OH, was cited for significant deviations from an investigational plan during an FDA inspection. The inspection revealed multiple instances of non-compliance, including enrolling subjects who met exclusion criteria, treating subjects with incorrect medical devices, and failing to report serious adverse events to the sponsor in a timely manner. These findings indicate a serious lack of adherence to study protocols and regulatory requirements for clinical trials.