FDA 483 - Aparna Kalyan, M.D. - February 18, 2025

An FDA inspection of Aparna Kalyan, M.D. in Chicago, IL, a clinical investigator, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, safety laboratory tests were not performed for a subject across multiple study visits, and a subject received an incorrect dose of investigational product, leading to neutropenia.