FDA in­spec­tion of UCB fa­cil­i­ty in Bel­gium finds sev­er­al qual­i­ty is­sues

UCB, a Brus­sels-based bio­phar­ma­ceu­ti­cal com­pa­ny, had sev­er­al is­sues cit­ed by FDA in­spec­tors at a man­u­fac­tur­ing fa­cil­i­ty in Bel­gium, but the com­pa­ny is not pan­ick­ing.

Ac­cord­ing to a 483 re­port, the FDA in­spect­ed UCB’s man­u­fac­tur­ing fa­cil­i­ty in Braine-l’Alleud, Bel­gium, be­tween April 17 and 21 of this year, with in­spec­tors find­ing three sig­nif­i­cant ob­ser­va­tions.

The FDA found is­sues with the qual­i­ty unit at the fa­cil­i­ty sur­round­ing its con­trol of doc­u­ments. The re­port said that UCB had “un­con­trolled” logs record­ing clean­ing ac­tiv­i­ties in clas­si­fied ar­eas, among oth­er ex­am­ples of “un­con­trolled” logs be­ing used. In­spec­tors al­so found shred­ded doc­u­ments at the fa­cil­i­ty but had no as­sur­ance that the ma­te­ri­als did not con­tain qual­i­ty doc­u­ments.

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Recon Strategy

Boston, MA, USA