FDA 483 - Oscar G. Galvez, M.D. - August 03, 2022

An FDA inspection of Oscar G. Galvez, M.D. in Coral Gables, FL, a clinical investigator, revealed significant deviations in the conduct of an investigational study. Observations included administering incorrect doses of investigational product, enrolling subjects who did not meet inclusion criteria, and failing to maintain adequate and accurate case histories with missing laboratory results. These issues indicate a lack of adherence to the investigational plan and proper record-keeping.