Granules India's US Unit Gets One FDA Observation, Says Issue Resolved

Granules India Ltd. on Saturday said the US Food and Drug Administration issued a Form-483 with one observation to its wholly owned subsidiary Granules Pharmaceuticals, Inc. after a pre-approval inspection at its Virginia facility. 

The inspection, related to a first-to-file controlled substance abbreviated new drug application, was conducted from Monday to Friday.
The company said the observation was addressed and resolved during the course of the inspection.