Up­dat­ed: Form 483 for UCB's Swiss site notes de­fi­cien­cies in qual­i­ty con­trol op­er­a­tions

The FDA on Tues­day re­leased a pre­vi­ous­ly un­pub­lished Form 483 is­sued to UCB’s man­u­fac­tur­ing site in Fri­bourg, Switzer­land, with four ob­ser­va­tions in­clud­ing one that notes de­fi­cien­cies in the over­sight over qual­i­ty con­trol op­er­a­tions.

The nine-day in­spec­tion in June and Ju­ly for the drug sub­stance and bulk drug prod­uct man­u­fac­tur­er un­cov­ered more specifics, in­clud­ing how the dis­crep­an­cy in UCB’s “abil­i­ty to re­view, doc­u­ment, and in­ves­ti­gate all elec­tron­ic da­ta is a gap in your firm’s Da­ta In­tegri­ty Pro­gram,” the Form 483 says.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER