FDA 483 - Robert S. Falcone, M.D. - April 05, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 65d0681e-a70b-435a-8420-dfaa60eb45ab