New Delhi: Drug major Sun Pharmaceutical Industries said the US health regulator has issued Form 483 with six observations after an inspection of its Halol facility in Gujarat.
The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) of the company’s Halol facility from August 27, 2018, to August 31, 2018, Sun Pharmaceutical Industries said in a BSE filing.
“At the conclusion of the inspection, the agency issued a Form 483, with six observations,” it added.
The company, however, did not provide details about the observations issued.
The company will be submitting its response on the observations to the USFDA within 15 business days, Sun Pharma said, adding that it is committed to addressing these observations promptly.
As per the US health regulator, FDA Form 483 notifies the company’s management of objectionable conditions at the facility inspected.
The company had earlier in June this year received establishment inspection report (EIR) from the US health regulator for Halol facility.
“The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed,” Sun Pharma had said at that time.