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

Shares of Sun Pharmaceutical Industries on Friday closed at Rs 664.20 per scrip on BSE, down 1.84 per cent from its close

Press Trust of India  |  New Delhi 

Sun Pharma
FILE PHOTO: A bird flies past the logo of Sun Pharma installed on the facade of its corporate office in Mumbai | Photo: Reuters

Drug major Industries Friday said the US health regulator has issued Form 483 with six observations after an inspection of its in Gujarat.

The United States Food and Drug Administration (US FDA) conducted a pre-approval inspection (PAI) of the company's from August 27, 2018 to August 31, 2018, 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, 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

"The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed," had said at that time.

Shares of Industries today closed at Rs 664.20 per scrip on BSE, down 1.84 per cent from its close.

First Published: Fri, September 07 2018. 16:55 IST
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