FDA 483 - Roger A. Dailey, M.D. - October 02, 2019

An FDA inspection of Roger A. Dailey, M.D. in Portland, OR, from September 24 to October 2, 2019, revealed significant issues with data integrity in a clinical study. The firm failed to prepare or maintain adequate and accurate case histories, with discrepancies found between source documentation and electronic case report forms. This included numerous instances of undocumented adverse events and concomitant medications for multiple study subjects.