Intas Pharmaceuticals’ Indian facility hit with FDA warning letter, placed on import alert

In­tas Phar­ma­ceu­ti­cals has been is­sued an­oth­er warn­ing let­ter af­ter FDA in­spec­tors un­cov­ered ma­nip­u­lat­ed records and con­t­a­m­i­na­tion is­sues at its fa­cil­i­ty in Gu­jarat, In­dia fol­low­ing a 12-day in­spec­tion last May.

The warn­ing let­ter sent by the FDA on Nov. 21 notes four vi­o­la­tions in­clud­ing da­ta in­tegri­ty is­sues. This fol­lows a Form 483, sent to In­tas on May 12, de­tail­ing 15 ob­ser­va­tions. In­tas re­spond­ed on June 5, but the FDA deemed it “in­ad­e­quate” and placed In­tas on an Im­port Alert on Nov. 14, mean­ing the US can halt im­ports from the fa­cil­i­ty and with­hold the ap­proval of any new drugs that In­tas is man­u­fac­tur­ing un­til the vi­o­la­tions have been cor­rect­ed.

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