FDA 483 - Lydia Hernandez, M.D. - September 17, 2024

An FDA inspection of Lydia Hernandez, M.D., a clinical investigator in Cincinnati, revealed significant deficiencies in the conduct of an investigational study. The firm failed to submit 15 serious adverse events to the sponsor within the required protocol timeframes, with delays ranging from 12 to 831 days. Additionally, records related to the return of investigational devices, including an investigational system and probes, were incomplete or missing.