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

An FDA inspection of Clinical Investigator Elizabeth Mones, M.D., located in Miami, FL, was conducted from June 24, 2024, to July 3, 2024. This compliance inspection, carried out under the Bioresearch Monitoring program (CP 7348.811), focused on Dr. Mones' conduct of a clinical trial involving an investigational drug regulated by the Federal Food, Drug and Cosmetic Act. The inspection identified two objectionable conditions, detailed in an FDA Form 483. First, the investigation was not conducted according to the approved investigational plan (21 CFR 312.60). Specifically, a study subject experiencing an adverse event was not discontinued from the trial as mandated by the protocol, despite not meeting the criteria for continuation. Second, Dr. Mones failed to maintain adequate and accurate case histories (21 CFR 312.62(b)). This involved altering medical records, such as MRI/CT scan reports, by obscuring subject identity, which made them difficult to attribute to specific participants. Additionally, some reports lacked consistency with the diagnostic inclusion criteria. Dr. Mones was represented by her Site Director during the exit interview, where the observations were acknowledged. A voluntary written response to the FDA Form 483 was subsequently submitted by Dr. Mones on July 25, 2024, outlining her proposed corrective actions.