U.S. FDA issues VAI classification to Granules arm Virginia facility
The U.S. FDA has classified the Granules Pharmaceuticals Inc. facility in Virginia with a voluntary action indicated (VAI) status following an inspection. The inspection revealed four observations, but the FDA is not recommending any regulatory action at this time. Granules India emphasized its commitment to quality and compliance in its manufacturing operations.
- ▪The FDA issued a VAI classification to the Granules Pharmaceuticals facility in Chantilly, Virginia.
- ▪The inspection took place from March 30 to April 3 and resulted in four Form 483 observations.
- ▪Granules India stated that the Virginia facility is crucial to its global manufacturing and supply network.
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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.
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