FDA 483 - Brian B. Borg, M.D. - September 01, 2023

An FDA inspection of Brian B. Borg, M.D., a clinical investigator, revealed significant deviations in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan, resulting in subjects receiving incorrect investigational product and improper infusion times. Additionally, the firm lacked adequate records for investigational drug disposition.