FDA 483 - Aukstuolis, Jim G., MD - February 01, 2019

An FDA inspection of Dr. Jim G. Aukstuolis, MD, a clinical investigator in Little Rock, AR, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan, specifically regarding the reporting of adverse events, proper handling of genetic samples, and IRB reporting. Additionally, critical investigational records, including source documentation for subject vitals, were not retained for the required period.