FDA 483 - Olga M. Lapeyra, M.D. - June 07, 2024

During an inspection conducted from May 28 to June 7, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Olga M. Lapeyra, M.D., a clinical investigator. The observations primarily highlighted instances where a clinical investigation was not conducted in adherence to the signed statement of the investigator and the approved investigational plan. Specifically, the FDA noted several discrepancies concerning subject eligibility and documentation. One subject, who was randomized and received the investigational product, did not meet a crucial inclusion criterion, as detectable levels of required medication were absent in their plasma assay. Furthermore, for two out of five enrolled subjects, essential plasma assay reports were not available for the clinical investigator’s review and evaluation prior to their randomization visit, a clear protocol requirement. A third observation revealed that three of the five reviewed subjects lacked adequate pharmacy or medical records to substantiate their adherence to background medication before screening, another specific inclusion criterion. These findings, reported under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicate conditions requiring attention. The firm is expected to address these observations by either discussing any objections or by implementing appropriate corrective actions to ensure compliance with regulatory standards for clinical investigations.