FDA 483 - Michelle Sato, M.D. - August 13, 2021

An FDA inspection of Michelle Sato, M.D. in Los Angeles, CA, a clinical investigator, revealed significant deficiencies in the conduct of an investigational plan. The firm failed to report all adverse events and lacked adequate oversight of study staff, who made unauthorized changes to study logs and examinations. These findings indicate serious non-compliance with clinical trial regulations.