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

An FDA inspection of Olga M. Lapeyra, M.D., a clinical investigator in Miami Lakes, FL, revealed a significant issue regarding the conduct of an investigation. The firm failed to adhere to the signed statement of investigator and investigational plan, specifically concerning subject eligibility, availability of plasma assay reports, and documentation of medication adherence. This indicates a serious deviation from clinical trial protocols.