Lupin’s Somerset Facility Receives Form-483 With 6 Observations From USFDA

Lupin's Somerset facility inspected by FDA from May 7-17, 2024, receiving a Form-483 with six observations. Shares dipped 0.018% to ₹1662.65.

Lupin, a pharmaceutical MNC, recently announced that the US Food and Drug Administration (FDA) conducted a pre-approved study at its manufacturing facility in Somerset, New Jersey. The inspection took place over a ten-day period, from May 7 to May 17, 2024, and it issued a certificate of complete -483 issued, detailing six findings by FDA inspectors.

In a formal statement to the Bombay Stock Exchange (BSE), Lupin stated, "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 when FDA investigators observe conditions that may violate the Food, Drug, and Cosmetic (FD&C) Act or other related regulations. These findings highlight areas of concern that need to be addressed to ensure compliance with regulatory standards.

Companies typically respond to such incidents with comprehensive maintenance programs. This policy aims to address issues identified by the FDA and bring operations into compliance with regulatory requirements.

Lupin assured that the findings are being handled properly and its response is being submitted to the FDA within the required timeframe.

The company made this disclosure in accordance with the SEBI (Listing Obligations and Disclosure Requirements) Regulations, Regulation 30 of 2015, to ensure transparency among stakeholders and the public.

The shares of the company close 0.018% down at ₹1662.65 per share on Saturday special trading session.