Lupin’s Somerset facility receives 6 observations in pre-approval USFDA inspection

21 May 2024 , 11:41 AM

Lupin Limited has reported that the US Food and Drug Administration (FDA) performed a pre-approval inspection of its manufacturing unit in Somerset, New Jersey. The inspection, which took place during May 7 to May 17, 2024, concluded with the issue of a Form-483, with six observations.

In a statement to BSE, Lupin stated, “We would like to inform you that the USFDA conducted 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 ended with the issue of a Form-483 with six observations.”

The issue of a Form-483 indicates that FDA inspectors observed probable regulatory infractions. USFDA investigators would have seen conditions that could be considered violations of the Food Drug and Cosmetic Act (FD&C) and related Acts.

Companies often respond to such observations with a thorough corrective action plan aimed at addressing and resolving the identified flaws in order to assure compliance with FDA rules.

Lupin said the business is thoroughly reviewing the findings and would respond to the USFDA within the timeframe specified.

Lupin Limited is an Indian multinational pharmaceutical corporation headquartered in Mumbai. It is among the world’s largest generic pharmaceutical firms in terms of revenue. Paediatrics, asthma, cardiovascular, diabetology, anti-infectives, and tuberculosis are among the company’s primary emphasis areas.

At around 11.36 AM, Lupin was trading 0.24% lower at ₹1,656.35 per piece, against the previous close of ₹1,660.30 on NSE. The counter touched an intraday high and low of ₹1,654.65, and ₹1,621.20, respectively.

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