USFDA

USFDA issues Form-483 with 4 observations to Lupin's Pithampur Unit-2 facility

USFDA inspected the facility from July 8 to 17, 2025, and closed with the issuance of a Form-483 with four observations, the Mumbai-based drug maker said in a regulatory filing. Drug firm Lupin on Saturday said the US health regulator has issued a Form-483 with four observations after inspecting its Pithampur Unit-2 manufacturing facility.

The US Food and Drug Administration (USFDA) inspected the facility from July 8 to 17, 2025, and closed with the issuance of a Form-483 with four observations, the Mumbai-based drug maker said in a regulatory filing.

"We would like to update that U.S. FDA has determined the inspection classification of this facility as 'Official Action Indicated (OAI)'," the drug maker said.

The company is working with the USFDA to satisfactorily resolve the compliance issues and is committed to being compliant with CGMP (current good manufacturing practice) standards at all its manufacturing facilities, it added.

Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts, as per the USFDA.

This development may have implications for Lupin’s operations and its standing in the pharmaceutical industry, particularly in the U.S. market.

Lupin Limited is a pharmaceutical company based in Mumbai, India, primarily engaged in the development, manufacture, and sale of a wide range of generic and branded formulations, biotechnology products, and active pharmaceutical ingredients. The company focuses on the global pharmaceutical market, with a significant presence in the United States and other international markets.