U.S. FDA classifies Aurobindo arm’s North Carolina plant VAI

Aurobindo Pharma on Monday (August 17, 2026) said the U.S. Food and Drug Administration (U.S. FDA) has issued Establishment Inspection Report (EIR) to subsidiary Aurolife Pharma’s plant in North Carolina classifying the facility as Voluntary Action Indicated.

With the unit classified as VAI, pending applications for multiple inhalers and other dosage forms filed from this facility can now progress through the U.S. FDA’s review process, the parent company stated.

The Raleigh Plant in North Carolina. It has been established for manufacturing inhalers, dermatology and transdermal products, was inspected by the U.S. FDA from March 24, 2025, to April 10, 2025. At the end of the inspection, it issued a Form 483 with 11 observations.

The unit has now received the EIR. The U.S. FDA has concluded that this inspection is now closed, Aurobindo Pharma said. The company shares closed 1.99% lower on the BSE at ₹1,625 each.

Voluntary Action Indicated (VAI) is one of three classifications the U.S. FDA issues and means objectionable conditions or practices were identified during its inspection. Still, it is not for any administrative or regulatory action. Official Action Indicated (OAI). It means regulatory and/or administrative actions are recommended; and No Action Indicated (NAI) or no objectionable conditions or practices were found during inspection are the other two classifications.