FDA 483 - Donald J Garcia, Jr. M.D. - April 01, 2021

An FDA inspection of Donald J Garcia, Jr. M.D., a clinical investigator in Austin, TX, revealed a significant failure to comply with regulations regarding informed consent. The firm did not ensure that informed consent was obtained from human subjects prior to conducting study-related tests, specifically urine screening for eligibility. This indicates a lapse in protecting human subjects participating in clinical trials.