FDA 483 - Sanjay Ramteke, M.D. - May 23, 2025

Sanjay Ramteke, M.D., a clinical investigator in Nagpur, India, was cited for failing to adhere to an investigational plan. Specifically, the firm did not discontinue an investigational product for a study subject who experienced neutropenia, a serious adverse event. This lapse resulted in the subject receiving another round of the study drug despite the adverse reaction.