FDA 483 - Rowena Punzalan, M.D. - February 07, 2025

Rowena Punzalan, M.D., a clinical investigator in Milwaukee, WI, was cited for significant deficiencies in conducting clinical investigations. Observations included failures in adhering to investigational plans, maintaining accurate case histories, and promptly reporting serious adverse events, including a subject's death, to the sponsor and IRB. These issues indicate a lack of proper oversight and adherence to study protocols and regulatory requirements.