FDA 483 - Tae H. Chung, M.D. - December 05, 2023

An FDA inspection of Tae H. Chung, M.D. in Baltimore, MD, a clinical investigator, revealed significant deviations from the investigational plan and failures in maintaining accurate study records. The firm failed to adhere to protocol requirements for subject eligibility, testing procedures, and completion of assessments, leading to subjects receiving investigational product without proper evaluations. Additionally, the inspection found a lack of contemporaneous source documentation for physical examinations in several subject case histories.