FDA 483 - Mukesh B. Chandre, MD MBBS - May 09, 2025

An FDA inspection of Mukesh B. Chandre, MD MBBS, a clinical investigator in Nashik, Maharashtra, India, revealed two significant observations. The firm failed to maintain accurate case histories, specifically regarding discrepancies in signing investigational product preparation worksheets. Additionally, the firm failed to conduct a foreign clinical study in accordance with Good Clinical Practices, as the informed consent document contained unproven claims about the investigational product's effectiveness.