Strug­gles with FDA con­tin­ue for Lupin as it is hand­ed an­oth­er Form 483

Trou­bled gener­ics man­u­fac­tur­er Lupin has strug­gled with FDA clean­ing and process val­i­da­tion guide­lines for the past four years. Now, the In­di­an com­pa­ny’s been hit with an­oth­er Form 483, fol­low­ing an in­spec­tion car­ried out be­tween March 22 and April 4.

The ci­ta­tion is in re­gards to vi­o­la­tions at the Tara­pur, In­dia man­u­fac­tur­ing fa­cil­i­ty. A let­ter ad­dressed to the Na­tion­al Stock Ex­change of In­dia is dat­ed April 5.

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