FDA 483 - Kevin R. Bender, M.D. - December 16, 2022
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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.
ID · 194179ed-555a-4ffa-a09d-58e4bfd488e4