FDA in­spec­tion at Catal­ent’s Bel­gium fa­cil­i­ty un­cov­ers da­ta, equip­ment and oth­er QC is­sues

On­ly a month af­ter FDA in­spect­ed Catal­ent’s site in In­di­ana, a site in Eu­rope has sim­i­lar­ly re­ceived an in­spec­tion re­port from US reg­u­la­tors, this time with nine ob­ser­va­tions.

The Form 483, is­sued af­ter an Au­gust in­spec­tion of Catal­ent’s man­u­fac­tur­ing site in the Bel­gian cap­i­tal of Brus­sels, cites is­sues with air fil­ters in asep­tic ar­eas, de­fi­cient changes to the HVAC sys­tem in­side of the clean rooms used for fill­ing, and equip­ment is­sues.

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