Lupin Limited has announced that the US Food and Drug Administration (FDA) concluded a pre-approval inspection of its manufacturing facility in Somerset, New Jersey. The inspection, conducted from May 7 to May 17, 2024, resulted in the issuance of a Form-483 with six observations.
In a statement to the Bombay Stock Exchange (BSE), Lupin disclosed, “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.”
A Form-483 is issued by the FDA when its inspectors observe any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. These observations are of regulatory significance and highlight areas where the facility may not be fully compliant with the FDA’s standards.
Lupin stated that it is addressing the observations comprehensively and will respond to the US FDA within the stipulated timeframe. “We are committed to addressing these observations promptly and thoroughly,” the company assured.
The issuance of Form-483 typically requires the company to submit a detailed corrective action plan to the FDA, outlining steps to resolve the identified issues and ensure future compliance with all regulatory requirements. This announcement was made in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, as stated by Lupin in its communication to BSE.
Lupin’s Somerset facility is crucial to its operations, and the company remains focused on maintaining high standards of quality and compliance. The prompt addressing of the FDA’s observations is a critical step in upholding the facility’s standing and ensuring the continuous supply of quality pharmaceutical products to the market.
