Cadila Healthcare has 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 today.
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 the company management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.“
Shares of Cadila Healthcare ended the session up by 19.94 per cent at Rs 429.45 on the BSE.