FDA hits Natco with warning letter over India facility, suspends product shipments to US

Man­u­fac­tur­er Nat­co Phar­ma was hit with a warn­ing let­ter ear­li­er this month over vi­o­la­tions at its fa­cil­i­ty in the In­di­an state of Telan­gana, fol­low­ing an in­suf­fi­cient re­sponse to an FDA Form 483 last fall.

Un­til the drug­mak­er shows how it fixed the is­sues in the warn­ing let­ter, Nat­co has sus­pend­ed mak­ing prod­ucts at the fa­cil­i­ty for the US, the agency said.

Among the vi­o­la­tions that were laid out in the April 8 let­ter, the FDA said the fa­cil­i­ty failed to ad­e­quate­ly clean, san­i­tize or ster­il­ize equip­ment at the rate that would pre­vent con­t­a­m­i­na­tion or mal­func­tion. It al­so said Nat­co didn’t ad­e­quate­ly in­ves­ti­gate un­ex­plained dis­crep­an­cies in batch­es of prod­uct, in­clud­ing miss­ing records.

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