Drug major Sun Pharmaceutical Industries June 21 said it has received four observations from the US health regulator for its Halol facility in Gujarat.
The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAl) of company’s Halol facility from June 3 to June 11, 2019, Sun Pharma said in a filing to the BSE.
“At the conclusion of the inspection, the agency issued a Form 483, with four observations,” it added.
The company will submit its response on the observations to the USFDA within 15 business days, Sun Pharma said.
The company “is committed to addressing these observations promptly,” it added.
As per the USFDA, Form 483 notifies the company’s management of objectionable conditions at a facility.
Sun Pharma, however, did not disclose the nature of the observations made by the US regulator.
Shares of Sun Pharmaceutical Industries Friday closed at Rs 382.80 per scrip on the BSE, down 2 per cent from its previous close.