FDA 483 - James W. Findling, M.D. - August 02, 2019

An FDA inspection of Dr. James Findling, Clinical Investigator, in Milwaukee, WI, from July to August 2019, revealed significant issues with clinical study conduct and IRB reporting. The firm failed to follow the investigational plan regarding subject eligibility, randomization, withdrawal, and dose adjustments. Additionally, the site did not ensure proper IRB oversight by failing to report significant protocol deviations and adverse events in a timely manner.