Granules U.S. unit completes USFDA audit
The Hindu
Describing the two observations as minor, the company said the audit was a pre-approval inspection for three products filed from the facility.
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.More Related News