FDA 483 - Jatin Vadhvana, M.B.B.S. - March 31, 2023

An FDA inspection of Jatin Vadhvana, M.B.B.S. in Ahmedabad, Gujarat, India, a clinical investigator, revealed deficiencies in informed consent procedures. The firm failed to ensure prospective subjects had sufficient opportunity to consider participation and minimized coercion or undue influence. Specifically, illiterate subjects were enrolled using compensated impartial witnesses who routinely provided this service.