Sun Pharma gets 6 observations by US FDA after inspection at Halol facility

Drug major Sun Pharmaceutical Industries Friday 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 (US FDA) 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.