FDA 483 - Robert S. Falcone, M.D. - April 05, 2021

An FDA inspection of Amici Clinical Research LLC in Raritan, NJ, a clinical investigator, revealed significant issues with adherence to study protocols and accurate record-keeping. The firm failed to conduct an investigation in accordance with the signed statement of investigator, leading to incorrect drug dosing for subjects. Additionally, the firm did not maintain accurate case histories, with discrepancies found in dose volumes recorded in electronic source documentation.