FDA lays the ham­mer on Emer­gen­t's Bal­ti­more plant af­ter J&J de­ba­cle, halt­ing all pro­duc­tion in un­usu­al move

Emer­gent BioSo­lu­tions has had a tough month: First, the CD­MO ru­ined 15 mil­lion dos­es of J&J’s Covid-19 vac­cine in March and then suf­fered the ig­nominy of the FDA seiz­ing the reins. Now, as the agency re­ceives a full ac­count­ing of the site’s prob­lems, Emer­gent has slammed the brakes on all pro­duc­tion at the FDA’s be­hest.

Emer­gent will cease man­u­fac­tur­ing at its Bal­ti­more plant un­til the FDA’s in­spec­tion and re­me­di­a­tion of any find­ings is com­plete, the com­pa­ny said in a state­ment. Emer­gent will al­so quar­an­tine ex­ist­ing ma­te­ri­als that have al­ready been man­u­fac­tured. That stop­page start­ed on Fri­day, four days af­ter the ini­ti­a­tion of the FDA’s in­spec­tion.

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