FDA 483 - Saji Jacob, MD - April 28, 2022

An FDA inspection of Saji Jacob, MD, a clinical investigator in St Louis, MO, revealed significant deficiencies in clinical trial conduct. Observations included improper informed consent documentation, failure to adhere to the investigational plan by enrolling ineligible subjects, and inadequate maintenance of case histories. These findings indicate a lack of proper oversight and documentation in the clinical study.