FDA 483 - Alan E. Kimura, M.D. - October 04, 2019

Alan E. Kimura, M.D. in Golden, CO, a clinical investigator, received an FDA Form 483 with two observations. The inspection revealed that investigational product was administered by unqualified staff, contrary to the study protocol. Additionally, the firm failed to maintain adequate case histories, as original source documents for investigational product dispensing were missing for multiple subjects.