FDA 483 - Intra-Cellular Therapies Inc - March 22, 2019

INTRA-CELLULAR THERAPIES INC in New York, NY, was cited for significant deficiencies during an FDA inspection of its sponsor activities. The firm failed to ensure that investigations were conducted according to the investigational plan and protocols, specifically regarding the recording and reporting of prohibited concomitant medications and protocol deviations. Additionally, the firm did not ensure proper monitoring of studies or adequate reporting of adverse events by clinical investigators.