FDA Flags Indian Drug Maker Lupin’s NJ Plant

SOMERSET, NJ -Major drug maker Lupin said on April 18 that the US Food and Drug Administration (USFDA) has issued a ‘Form 483’ with three observations to the company’s manufacturing facility in Somerset, New Jersey, following a recent inspection.

According to the USFDA, a Form 483 is issued to a company’s management at the end of an inspection when investigators observe conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related regulations.

In a regulatory filing, Lupin said the inspection was conducted between April 13 and April 17.

The company added that it will address the observations and respond to the USFDA within the stipulated timeframe.

Lupin also said it remains committed to maintaining compliance with current Good Manufacturing Practices standards across all its facilities.

Earlier in March, the USFDA concluded an inspection at Lupin’s Ankleshwar manufacturing facility in India, conducted from March 2 to March 7, which also resulted in a Form 483 carrying two observations.

The company had said it would address those observations and respond within the required timeline while maintaining compliance with cGMP standards.

Shares of Lupin on April 19 ended at Rs 2,322.50, down 0.19 per cent on the NSE. The stock has touched a 52-week high of Rs 2,377.60 and a 52-week low of Rs 1,836.80 on the exchange. (IANS)