Lupin announced that the US Food and Drug Administration (FDA) has concluded its inspection of the company’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.

According to a stock exchange filing, the inspection was carried out between July 8 and July 17, 2025. Following the inspection, the US FDA has classified the facility under “Official Action Indicated” (OAI).

Lupin stated that it is working with the regulator to resolve the compliance issues, reiterating its commitment to adhering to current Good Manufacturing Practice (cGMP) standards across all its manufacturing facilities.

Lupin operates 15 state-of-the-art manufacturing facilities, which are spread across India, the United States, Brazil and Mexico.