FDA 483 - Chafic Karam, M.D. - May 03, 2021

An FDA inspection of Chafic Karam, M.D. in Portland, OR, a clinical investigator, revealed significant issues in the conduct of an investigational drug study. The firm failed to adhere to the investigational plan and protocol, leading to improper subject enrollment, incorrect assessment procedures, and inadequate documentation. Additionally, the inspection found a failure to maintain accurate case histories, with numerous data discrepancies between source documents and electronic records.