Lupin Gets US FDA Observations For Two Pithampur Units

Lupin Ltd. on Thursday said the US Food and Drug Administration has issued Form 483 to two of its units at the Pithampur facility. The regulator raised four observations for Unit-2 and three for Unit-3, the company said in an exchange filing.

The inspections were conducted between July 7-17, and Lupin said it is addressing the issues and will respond to the US FDA within the stipulated timeframe.