FDA 483 - Claudia R. Padilla, M.D. - November 12, 2021

An FDA inspection of Claudia R. Padilla, M.D. in Dallas, TX, revealed significant deviations from the investigational plan during a clinical study. The firm failed to document the review of electrocardiograms for multiple subjects as required by the protocol. Additionally, laboratory specimens were improperly stored on-site and shipped late, rendering them beyond stability for analysis.