The United States Food and Drug Administration (U.S. FDA) has issued an Official Action Indicated (OAI) classification to Aurobindo Pharma subsidiary Eugia Pharma Specialities’ formulation manufacturing facility near Hyderabad.OAI is one of the three classifications the regulator categorises post its inspection and it means regulatory and/or administrative actions are recommended.The U.S. FDA had inspected the facility of Eugia Pharma’s, in Kolthur village of Ranga Reddy district, from February 16-27 and issued four observations. Aurobindo Pharma said “the FDA has now determined the inspection classification of this facility is official action indicated (OAI).”The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, it said in a filing on Sunday, May 24, 2026.The other two classifications the U.S. FDA issues, after inspections, are No Action Indicated (NAI) conveying that no objectionable conditions or practices were found during inspection; and Voluntary Action Indicated (VAI) meaning objectionable conditions or practices were found, but it is not prepared to take or recommend any administrative or regulatory action. Published - May 25, 2026 09:41 pm IST
U.S. FDA classifies Aurobindo arm’s formulation unit Official Action Indicated (OAI)
The United States Food and Drug Administration (U.S. FDA) has issued an Official Action Indicated (OAI) classification to Aurobindo Pharma subsidiary Eugia Pharma Specialities’ formulation manufacturing facility near Hyderabad.














