"United States Food and Drug Administration (USFDA) inspected its (the company's) Dabhasa facility from 29th June to 6th July 2016. At the end of the inspection, two 483s were issued," Lupin said in a filing to BSE.
Both the observations are minor in nature and corrective and preventive actions were shown to the inspectors during the inspection, it added.
As per the USFDA, the purpose of a "Form 483 is to notify the company's management of objectionable conditions". An FDA Form 483 is issued to firm management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."
he inspection has been classified as Voluntary Action Indicated, Lupin said.
Shares of Lupin today closed at Rs 1,637.30 per scrip on BSE, down 1.21 per cent from its previous close.
As per the USFDA, the purpose of a "Form 483 is to notify the company's management of objectionable conditions". An FDA Form 483 is issued to firm management at the conclusion of an inspection "when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."
he inspection has been classified as Voluntary Action Indicated, Lupin said.
Shares of Lupin today closed at Rs 1,637.30 per scrip on BSE, down 1.21 per cent from its previous close.
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