FDA 483 - Ravi Ganeshappa, M.D. - June 30, 2023

Ravi Ganeshapp, M.D., a clinical investigator in San Antonio, TX, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. The inspection revealed significant deviations, including errors in subject inclusion criteria and the incorrect dispensing of investigational drug product instead of a placebo to a study subject. These findings indicate a lack of adherence to study protocols and proper oversight in clinical trial conduct.