Lupin Limited announced that its facility in the US received six observations. 

In its regulatory filing, the company said that the US Food and Drug Administration (USFDA) conducted a pre-approval inspection at its manufacturing facility in Somerset, New Jersey, between 7 May and 17 May 2024. 

The US regulatory concluded the inspection and issued a Form-483 with six observations. 

The filing added, “We would like to inform you that the US FDA concluded a pre-approval inspection at Lupin’s Somerset, New Jersey, manufacturing facility. The inspection was conducted from May 7, 2024, to May 17, 2024, and closed with an issuance of a Form-483 with six observations.”

The issuance of Form-483 with observations indicates potential violations of regulatory significance. The USFDA investigators would have observed conditions that may constitute a violation of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Companies respond to these observations with a detailed corrective action plan with an aim to address and resolve the identified issues, ensuring compliance with the FDA regulations. 

The company said that they will address the observations comprehensively within the stipulated time frame.