Granules India gets 2 USFDA observations for Chantilly facility
New Delhi: Drug firm Granules India on Monday said the US health regulator has issued two observations after the inspection of the Chantilly facility of its US-based subsidiary."The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company located in Chantilly, Virginia, USA on June...
New Delhi: Drug firm Granules India on Monday said the US health regulator has issued two observations after the inspection of the Chantilly facility of its US-based subsidiary.
"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals, a wholly owned foreign subsidiary of the company located in Chantilly, Virginia, USA on June 25, 2021, with two minor observations," Granules India said in a statement.
This is a pre-approval inspection for the products filed from this facility, it added.
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"We will be responding to the two observations within the stipulated time period," Granules Pharmaceuticals Executive Director Priyanka Chigurupati said.
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