U.S. FDA issues VAI classification to Granules arm Virginia facility

The U.S. Food and Drug Administration (U.S. FDA) has issued an establishment inspection report (EIR) with a voluntary action indicated (VAI) classification to the Granules Pharmaceuticals Inc. (GPI) facility in Chantilly, Virginia.

The regulator had inspected the facility from March 30 to April 3 and issued four Form 483 observations. In a filing on Wednesday, about the VAI classification, parent company Granules India said the facility plays an important role in its global manufacturing and supply network.

The company remains committed to maintaining the highest standards of quality, safety, and regulatory compliance across its facilities in India and the US, it said. Granules India shares closed 2.08% higher on the BSE at ₹793 each.

VAI is one of three classifications the U.S. FDA issues, which means that while objectionable conditions or practices were found, the regulator is not prepared to take or recommend any administrative or regulatory action.

Under OAI, another classification, regulatory and/or administrative actions are recommended. The third classification, No Action Indicated (NAI), conveys that no objectionable conditions or practices were found during inspection.