FDA 483 - Jose Luis Bautista, M.D. - October 06, 2021

Jose Luis Bautista, M.D., a clinical investigator in Fresno, CA, was cited for two significant issues during an FDA inspection. The observations detail failures to conduct an investigation according to the protocol, with multiple subjects missing required assessments, and a failure to report serious adverse events to the sponsor in a timely manner. These findings indicate serious deviations from clinical trial regulations.