FDA 483 - Kevin R. Bender, M.D. - December 16, 2022

DBC Research Corp., a clinical investigator in Tamarac, FL, was inspected by the FDA and received a Form 483 with three observations. The findings indicate significant issues with the control and accountability of investigational drugs, including the loss of a controlled substance shipment. Additionally, the firm failed to maintain accurate and contemporaneous subject source documents regarding investigational product disposition and case histories, with instances of improper attribution of tasks.