FDA 483 - Cem Akin, M.D. - May 10, 2023

Cem Akin, M.D., a clinical investigator in Ann Arbor, MI, received a Form FDA 483 for failing to conduct an investigation in accordance with the investigational plan. The primary issue involved not obtaining required pregnancy tests for women of childbearing potential every (b)(4) as mandated by the study protocol. This resulted in numerous late tests for multiple subjects, indicating a significant deviation from established procedures.