FDA 483 - Olga M. Lapeyra, M.D. - October 25, 2021

An FDA inspection of Olga M. Lapeyra, M.D., Clinical Investigator, revealed significant deficiencies in the conduct of a clinical study. The firm failed to maintain adequate case histories, specifically regarding investigational product dosage documentation for multiple subjects. Additionally, the investigation was not conducted according to the protocol, as the firm did not properly monitor and report temperature excursions for the investigational product.