FDA 483 - Hessam Aazami, M.D. - February 04, 2020

An FDA inspection of Hessam Aazami, M.D. in Canoga Park, CA, revealed a significant issue with record retention. The firm failed to retain original source records for electronic diaries for a large number of enrolled subjects following the approval of a drug's marketing application. This indicates a serious lapse in maintaining investigational records.