FDA 483 - Rafaelito S. Victoria, MD - June 10, 2022

This FDA Form 483 was issued to Rafaelito S. Victoria, Clinical Investigator, in La Palma, CA, following an inspection from May 31 to June 10, 2022. The inspection revealed significant deficiencies in the conduct of clinical investigations, including protocol deviations, inadequate drug accountability, insufficient informed consent processes, and inaccurate case histories. These issues indicate a lack of control over critical aspects of clinical trial management.