FDA 483 - Elizabeth Mones, M.D. - July 03, 2024

The FDA inspected Health Care Family Rehab And Research Center in Hialeah, FL, a clinical investigator, and found two significant issues. The firm failed to conduct an investigation according to the protocol by not discontinuing a subject who experienced an adverse event. Additionally, the firm failed to maintain adequate and accurate case histories, as medical records were not attributable to specific subjects and MRI/CT scan reports were altered and sometimes illegible.