FDA 483 - Juan M. Ruiz-Unger, M.D. - September 22, 2021

The FDA issued a Form 483 to Juan M. Ruiz-Unger, M.D., a clinical investigator in Palmetto Bay, FL, following an inspection that revealed significant deviations from the investigational plan. The firm failed to confirm subject eligibility criteria, conduct required safety screenings, and properly review or document laboratory reports for subjects enrolled in a clinical study. These deficiencies resulted in the randomization and treatment of subjects who did not meet the study's protocol requirements.