New Delhi, April 18 Major drug maker Lupin on Saturday said that the US health regulator has issued a 'Form 483' with three observations to its manufacturing facility in Somerset, New Jersey, following a recent inspection.
In a regulatory filing, the pharmaceutical company said that the inspection by the US Food and Drug Administration (USFDA) was conducted this week between April 13 and April 17.
"The inspection was completed with the issuance of a Form 483 carrying three observations," the drug maker said.
The company further 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 (cGMP) standards across all its facilities.
Earlier in March, the USFDA had concluded an inspection at the company’s Ankleshwar manufacturing facility in India -- conducted from March 2 to March 7-- which also resulted in a Form 483 with two observations.
The company had said at the time that it would address the observations and respond within the required timeline, while maintaining compliance with cGMP standards.
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.
Shares of Lupin on Friday ended at Rs 2,322.50, a decrease of 0.19 per cent, on the NSE. Moreover, the pharma 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.
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