FDA 483 - Elaine E. Tseng, M.D. - January 07, 2022

An FDA inspection of Elaine E. Tseng, M.D. in San Francisco, CA, from January 4-7, 2022, identified a critical deficiency in the reporting of serious adverse events. The clinical investigator and study staff failed to report all serious adverse events (SAEs) to the sponsor within the timeframe required by the study protocol. Specifically, four out of 24 SAEs occurring at the study site were reported late.