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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER