FDA 483 - Salil U. Nadkarni, DO - September 24, 2021

An FDA inspection of Salil U. Nadkarni, DO, a clinical investigator in Los Angeles, CA, revealed a significant deviation from the investigational plan. The firm failed to ensure subjects met the required compliance for completing headache diaries during screening, impacting subject eligibility for a clinical trial. This indicates a failure to conduct the investigation in accordance with the protocol.