Siddharth Mittal, Biocon CEO

A month af­ter Bio­con was hand­ed a Form 483, doc­u­ments re­veal lack­lus­ter con­di­tions

In Sep­tem­ber, Bio­con got out in front of a Form 483 it was hand­ed by the FDA in a rare out-of-the-coun­try in­spec­tion, in­sist­ing that the hic­cup would not hin­der its plans for the com­mer­cial­iza­tion of in­sulin as­part in the US.

Now, af­ter it’s been re­leased to the pub­lic, that Form 483 high­lights an un­qual­i­fied dis­tri­b­u­tion sys­tem, in­ad­e­quate asep­tic mon­i­tor­ing and leaky drains, among oth­er is­sues at its Malaysia sub­sidiary.

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