Drugmaker Granules on June 28 said wholly owned subsidiary Granules Pharmaceuticals Inc. (GPI) facility in Chantilly, Virginia has completed an audit by the U.S. Food and Drug Administration (USFDA) with two observations.
Describing them as minor observations, the company said the audit was a pre-approval inspection for three products filed from the facility.
The inspection was conducted by the regulator from June 21 to 25. “We will be responding to the two observations within the stipulated time period,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals Inc.
Spread over 1,00,000 sq ft, the GPI facility has research and development and manufacturing capabilities for low volume, oral solid dosage forms, a release from Granules India said.
