An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new de­tails of what needs fix­ing, Lupin dis­closed last week that the FDA re­cent­ly sent a warn­ing let­ter to its Tara­pur, In­dia-based site.

Af­ter an in­spec­tion from March 22 to April 4, Lupin dis­closed in an April stock fil­ing that it re­ceived a Form 483 with four ob­ser­va­tions, but it didn’t of­fer any de­tails on the ob­ser­va­tions.

Sim­i­lar to com­ments made in April, the com­pa­ny said last week it does not be­lieve the FDA slap will dis­rupt its drug sup­plies or the ex­ist­ing rev­enues from op­er­a­tions of this fa­cil­i­ty.

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