FDA 483 - Ibrahim Amjad, M.D. - July 28, 2021

An FDA inspection of Amjad Plastic Research in West Miami, FL, a clinical investigator, revealed a significant issue with the control of investigational product. The firm failed to maintain proper control over both used and unused investigational products, leading to unauthorized disposal and issues with expired and missing kits. This indicates a serious lapse in adherence to clinical investigation protocols.