FDA 483 - Rosa Maria Jimenez Rodriguez, M.D.,Ph.D. - December 20, 2024

An FDA inspection of Rosa Maria Jimenez Rodriguez, M.D.,Ph.D., a clinical investigator in Sevilla, Spain, revealed significant deficiencies in maintaining adequate case histories. The firm failed to document appropriate storage conditions for investigational product infusions, administered doses contrary to the IP manual, and incorrectly calculated a subject's screening score. These findings indicate serious issues with data integrity and adherence to study protocols.