Drug firm Cadila Healthcare today said the US health regulator has inspected the company's Moraiya plant and found it meeting the manufacturing norms.
"United States Food and Drug Administration (USFDA) inspected company's Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection no observation (483) is issued," Cadila Healthcare said in a filing to BSE.
The FDA Form 483 notifies the company's management of objectionable conditions.
As per the US health regulator's site "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".
Shares of Cadila Healthcare were trading at Rs 420.10 per scrip in the afternoon trade today on BSE, up 17.33 per cent from its previous close.
"United States Food and Drug Administration (USFDA) inspected company's Moraiya facility from February 6, 2017 to February 15, 2017. At the end of the inspection no observation (483) is issued," Cadila Healthcare said in a filing to BSE.
The FDA Form 483 notifies the company's management of objectionable conditions.
As per the US health regulator's site "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".
Shares of Cadila Healthcare were trading at Rs 420.10 per scrip in the afternoon trade today on BSE, up 17.33 per cent from its previous close.