Catal­ent’s Covid-19 vac­cine man­u­fac­tur­ing site hit with Form 483 over for­eign ob­jects in vials and oth­er QC is­sues

An In­di­ana-based Catal­ent fa­cil­i­ty that pro­duces Covid-19 vac­cines is fac­ing scruti­ny from the FDA over an in­spec­tion last month.

Catal­ent’s plant in Bloom­ing­ton, IN, which han­dles fill and fin­ish op­er­a­tions as well as com­mer­cial scale bio­man­u­fac­tur­ing, was hit with a 19-page Form 483 from the FDA. The in­spec­tion re­port­ed a to­tal of 12 ma­jor ob­ser­va­tions made when the fa­cil­i­ty was in­spect­ed be­tween Aug. 1 and Sept. 1.

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