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.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

Consultant

Recon Strategy

Boston, MA, USA