Nec­tar Life­sciences hit with un­ti­tled let­ter over re­peat GMP is­sues at an­timi­cro­bial site

In­di­an API man­u­fac­tur­er Nec­tar Life­sciences late last month re­ceived an un­ti­tled let­ter from the FDA over re­peat GMP vi­o­la­tions, the FDA said, fol­low­ing a sev­en-day in­spec­tion at its Unit VI site in Hi­machal Pradesh, In­dia, last March.

Dur­ing the in­spec­tions, the FDA un­cov­ered im­prop­er asep­tic man­u­fac­tur­ing op­er­a­tions to pre­vent mi­cro­bi­o­log­i­cal con­t­a­m­i­nants. The fa­cil­i­ty in­spect­ed man­u­fac­tures the be­ta-lac­tam an­timi­cro­bial cephalosporin, used in tablets, cap­sules, dry syrups, ster­ile pow­der in­jec­tions and gran­ules.

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