FDA 483 - Gautam T. Jayram, M.D. - January 23, 2026

An FDA inspection of Urology Associates, Pc Research Department in Nashville, TN, revealed significant deficiencies in clinical investigation practices. The firm failed to maintain adequate and accurate case histories, did not conduct investigations in accordance with the investigational plan, and had inadequate investigational drug disposition records. These issues indicate serious concerns regarding data integrity and adherence to protocol requirements in clinical research.