FDA 483 - Hugo Llanes JR, M.D. - May 19, 2022

Hugo Llanes JR, M.D., a clinical investigator in Hialeah, FL, was cited for failing to prepare and maintain adequate and accurate case histories during an FDA inspection. The report details significant data integrity issues, including inaccurate, missing, non-contemporaneous, and non-original data for multiple subjects across two clinical protocols. These deficiencies impacted critical study data, subject eligibility, and investigational product accountability.