FDA 483 - Charles E. Canter, MD - December 20, 2021

An FDA inspection of Charles E. Canter, MD in St Louis, MO, a clinical investigator site, revealed significant deficiencies in the conduct of an investigational study. Observations included failures to confirm subject exclusion criteria, document investigator review of eligibility, and confirm end-of-study visits. Additionally, inadequate investigational drug disposition records and incomplete case histories were noted.