FDA 483 - Leslie H. Lundahl, PhD - December 15, 2023

Leslie H. Lundahl, PhD, a sponsor-investigator in Detroit, MI, was cited for significant non-compliance regarding an Investigational New Drug (IND). The firm failed to submit annual reports for an IND since 2018, resulting in its termination, while continuing to enroll and dose subjects. Additionally, protocol amendments for the study were not submitted when changes went into effect.