FDA find­ings at Mod­er­na's Mass­a­chu­setts fa­cil­i­ty don't re­flect qual­i­ty, safe­ty con­cerns, com­pa­ny says

A Sep­tem­ber in­spec­tion of Mod­er­na’s man­u­fac­tur­ing plant in Nor­wood, MA, found laps­es in clean­ing pro­ce­dures and ex­pired prod­uct, ac­cord­ing to an agency re­port ob­tained by End­points News, but the com­pa­ny says the in­spec­tion isn’t cause for con­cern over qual­i­ty and safe­ty.

In a 483 in­spec­tion re­port ob­tained by End­points through a Free­dom of In­for­ma­tion Act re­quest, the agency not­ed five ob­ser­va­tions, in­clud­ing equip­ment for drug sub­stance man­u­fac­tur­ing that was not cleaned prop­er­ly be­fore us­age. Mod­er­na us­es the Nor­wood plant to man­u­fac­ture its Covid-19 vac­cine.

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