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And while End­points was un­able to find cas­es of pa­tients who had been harmed, FDA in­spec­tion re­ports from 2024 and 2022, and a warn­ing let­ter from 2021, say Em­pow­er failed to re­port ad­verse re­ac­tions to the agency with­in the re­quired time lim­its — which could make it hard­er to iden­ti­fy or track those po­ten­tial prob­lems

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doi: 10.1016/j.lfs.2020.117581