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.

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