FDA 483 - Jose Carlos Lopez Escobar, M.D. - July 03, 2024

An FDA inspection of Jose Carlos Lopez Escobar, M.D., operating as Health Care Family Rehab And Research Center in Hialeah, FL, identified a significant deficiency in clinical trial record-keeping. The firm failed to prepare or maintain adequate case histories for enrolled subjects. Specifically, five out of seven reviewed subjects lacked documentation confirming they met the inclusion criteria for prior Alzheimer's disease treatment.