FDA 483 - Jennifer L. Miller, M.D. - August 19, 2021

Jennifer L. Miller, M.D., a clinical investigator in Gainesville, FL, received an FDA Form 483 citing significant deficiencies during an inspection. The firm failed to conduct investigations in accordance with the investigational plan, specifically by not performing required tests and by failing to report numerous adverse events. Additionally, the firm did not maintain adequate and accurate case histories, leading to discrepancies in adverse event documentation and omitted concomitant medications.