Ger­man man­u­fac­tur­er hit with Form 483 for mul­ti­ple pro­duc­tion is­sues

Af­ter an in­spec­tion in Feb­ru­ary, the FDA has re­vealed con­cern­ing ob­ser­va­tions at a man­u­fac­tur­ing fa­cil­i­ty be­long­ing to Rentschler Bio­phar­ma in Ger­many.

The fa­cil­i­ty, a drug sub­stance man­u­fac­tur­ing site in the small south­ern Ger­man city of Laupheim, had nine ob­ser­va­tions not­ed by FDA in­spec­tors.

The first ob­ser­va­tion not­ed that the sim­u­lat­ed fill process had no RPM spec­i­fi­ca­tion for the pump and no doc­u­men­ta­tion for RPM set­tings dur­ing drug sub­stance dis­pens­ing to be avoid­ed. The process is al­so not con­trolled to an es­tab­lished spec­i­fi­ca­tion.

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