FDA 483 - Amandeep Salhotra, M.D. - December 04, 2025

An FDA inspection of Amandeep Salhotra, M.D., a clinical investigator in Duarte, CA, revealed a significant deficiency in the conduct of an investigation. The firm failed to report serious adverse events to the sponsor within 24 hours, as mandated by the study protocol. This indicates a failure to adhere to the investigational plan and investigator responsibilities.