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 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.
"We will be responding to the two observations within the stipulated time period," Granules Pharmaceuticals Executive Director Priyanka Chigurupati said.