FDA 483 - Priya U. Kumthekar, M.D. - April 28, 2023

An FDA inspection of Priya U. Kumthekar, M.D., a clinical investigator in Chicago, IL, revealed a significant deficiency in the conduct of an investigation. The firm failed to perform all protocol-required lab assessments for all fifteen enrolled subjects, indicating a deviation from the signed statement of investigator and investigational plan. This suggests a serious lapse in adherence to clinical trial protocols.