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Exclusive | US FDA finds procedural issues at Lupin’s Nagpur injectables plant

Lupin, in an exchange filing on October 30 acknowledging the receipt of the form 482, said that the inspection pertained to pre-approval of its unit two.

Mumbai / November 08, 2022 / 06:12 AM IST
 
 
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The US Federal Drug Administration (US FDA) found several procedural deficiencies at Lupin Limited’s injectables unit two in Nagpur following its inspection on October 17-29, according to the form 483 issued by the drug regulator and accessed by Moneycontrol.

A form 483 is issued by the US drug regulator after an inspection of a facility that has flouted the regulator’s good manufacturing norms.

Lupin, in an exchange filing on October 30 acknowledging the receipt of the form 483, said the inspection pertained to pre-approval of its unit two.

As per the form 483 issued by inspector Cynthia Jim, consumer safety officer,  the US FDA found the company’s Nagpur facility deficient on five counts.