FDA 483 - Keith M. Wan, O.D. - June 13, 2025

An FDA inspection of Keith M. Wan, O.D. in San Diego, CA, a clinical investigator, revealed significant deficiencies in clinical trial conduct. Observations included inadequate case histories with mismatched efficacy endpoint values, failure to adhere to the investigational plan by enrolling an ineligible subject, and inadequate investigational drug disposition records. These issues indicate a lack of control over study data and processes.