FDA 483 - Leadiant Biosciences, Inc. - July 08, 2021

Leadiant Biosciences, Inc. in Gaithersburg, MD, was inspected regarding post-marketing adverse drug experience reporting. The inspection revealed that the company failed to submit periodic reports for non-alert adverse drug experiences for an application approved three or more years ago. Specifically, over 300 adverse events for the drug Matulane were incorrectly reported as expedited individual case safety reports instead of periodic safety update reports.