Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The no­to­ri­ous drug test­ing com­pa­ny Val­isure, which has made a name for it­self by forc­ing FDA’s hand with some of its safe­ty-re­lat­ed un­cov­er­ings, re­ceived a let­ter this week af­ter the FDA un­cov­ered vi­o­la­tions at its Con­necti­cut-based test­ing lab in 2021.

The let­ter, which was sent on Dec. 5, stat­ed that the FDA is “con­cerned” that Val­isure was not aware of  drug sup­ply chain se­cu­ri­ty re­quire­ments.

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