What should man­u­fac­tur­ers do af­ter re­ceiv­ing a Form 483? FDA ex­plains

No man­u­fac­tur­er wants to be on the re­ceiv­ing end of the FDA’s Form 483. On Wednes­day, the agency spelled out what to do if they are.

483 forms are pro­vid­ed to man­u­fac­tur­ers if any vi­o­la­tions were ob­served dur­ing in­spec­tions. While the process is meant to en­sure that pa­tients are ac­cess­ing safe med­ica­tions, Of­fice of Reg­u­la­to­ry Af­fairs com­pli­ance of­fi­cer Re­bec­ca Asente as­sured the in­dus­try dur­ing a we­bi­nar on Wednes­day that it al­so al­lows an op­por­tu­ni­ty for “mean­ing­ful di­a­logue, which will hope­ful­ly pro­vide a bet­ter un­der­stand­ing of a man­u­fac­tur­er’s op­er­a­tions and the ex­pec­ta­tions of the FDA.”

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