FDA 483 - Ernie Riffer MD - June 23, 2023

An FDA inspection of Ernie Riffer MD, a clinical investigator in Phoenix, AZ, revealed significant issues with data management and recordkeeping. Observations included failures to maintain accurate case histories, conduct investigations according to the plan, and retain investigational records for the required period. These findings indicate deficiencies in the firm's adherence to regulatory requirements for clinical studies.