FDA 483 - Mitsubishi Tanabe Pharma Development America, Inc. - October 15, 2021

An FDA inspection of Mitsubishi Tanabe Pharma Development America, Inc. in Jersey City, NJ, identified two significant issues related to post-marketing adverse drug experience reporting. The firm lacked written procedures for reporting periodic safety reports, including quarterly and annual reports. Additionally, the company failed to submit two quarterly periodic adverse drug experience reports for Exservan within the required timeframe.