The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
Sun Pharmaceutical Industries said the US health regulator has issued three observations after inspecting its Halol facility in Gujarat. The United States Food and Drug Administration (US FDA) conducted the Good Manufacturing Practices (GMP) inspection of the company’s Halol facility from February 12-23, 2018, Sun Pharmaceutical Industries said in a BSE filing.
“At the conclusion of the inspection, the agency issued a Form 483, with three observations,” it added. The drug firm however did not disclose any detail of the observations.
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days, Sun Pharma said.
“The company is committed to addressing these observations promptly. The company remains committed to working closely with the USFDA and continues to enhance its GMP compliance on an ongoing basis,” it said.
As per the USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
It notifies the company’s management of objectionable conditions.
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