FDA 483 - Pratik Doshi, M.D. - March 07, 2025

An FDA inspection of Pratik Doshi, M.D., a bioequivalence clinical testing facility in Vadodara, Gujarat, India, identified one observation. The firm failed to meet general requirements for informed consent. Specifically, consent forms for a clinical research project included a statement that the study was "not of an experimental nature," which did not minimize the possibility of coercion or undue influence.