FDA issues 2 observations for Granules plant

FDA issues 2 observations for Granules plant
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Drug firm Granules India on Thursday said the US health regulator has issued two observations after inspection of Chantilly facility of its American arm in Virginia.

Hyderabad: Drug firm Granules India on Thursday said the US health regulator has issued two observations after inspection of Chantilly facility of its American arm in Virginia.

"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, USA, on August 21, 2019, with two minor observations," Granules India said in a filing to BSE.

This is a pre-approval inspection for seven products filed from this facility, it added. "Granules Pharmaceuticals Inc will respond to these observations within the stipulated time period," the company said.

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