US FDA issues Form 483 with seven observations for Lupin’s Goa plant

Lupin Ltd. on Friday said the US Food and Drug Administration has issued a Form 483 with seven observations for its manufacturing facility in Goa after a recent inspection. The regulator inspected the plant from Nov. 10 to Friday, the company said in an exchange filing.

The company said it will address the observations and respond to the US FDA within the stipulated timeframe, adding that it remains committed to compliance with Current Good Manufacturing Practice standards across all facilities.