FDA EIR - Clifford J Molin Md Ltd - September 22, 2016

An FDA Bioresearch Monitoring inspection of Dr. Clifford J. Molin, a Clinical Investigator located in Las Vegas, Nevada, was conducted from September 19 to September 22, 2016. This high-priority inspection, assigned by the Center for Biologics Evaluation and Research (CBER) under Compliance Program 7348.811 for Bioresearch Monitoring of Clinical Investigators, aimed to verify study data for a specific clinical protocol involving an investigational drug.The inspection thoroughly reviewed protocol adherence, investigator and staff qualifications, test article control, record retention, Institutional Review Board (IRB) correspondence, and human subject records. The report concluded that Dr. Molin generally complied with the overall requirements for the study protocol, maintained accurate and complete source documentation, and adhered to the protocol.Significantly, no Form FDA 483, Inspectional Observations, indicating formal regulatory violations, was issued at the inspection's conclusion. One minor issue was brought to management's attention: a study subject departed approximately three minutes before completing the required 30-minute post-injection observation. However, no adverse events were recorded for this subject, who completed the study. Management acknowledged this observation and committed to ensuring future mindfulness in observing study subjects. No formal corrective actions were required.