FDA hands a warn­ing let­ter to a Lupin sub­sidiary af­ter fail­ing to main­tain clean­li­ness once again

From In­dia to NJ, the core of the FDA’s in­struc­tions to Lupin sub­sidiary Nov­el Lab­o­ra­to­ries were the same: es­tab­lish prop­er clean­ing and process val­i­da­tion guide­lines at your man­u­fac­tur­ing sites. And af­ter fail­ing to do so for the third time in four years, the com­pa­ny has re­ceived a warn­ing let­ter.

Drug residue on tablet press­es and a fail­ure to val­i­date the man­u­fac­tur­ing process af­ter equip­ment changes were just two of the is­sues raised by the FDA af­ter an in­spec­tion of a Nov­el Lab­o­ra­to­ries plant that led to the June 11 let­ter.

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