Aurobindo Pharma’s Raleigh plant gets 'Voluntary Action Indicated' classification from US FDA

The US Food and Drug Administration (US FDA) on Monday classified Aurobindo Pharma Limited’s Raleigh manufacturing facility in North Carolina as “Voluntary Action Indicated” (VAI), closing an inspection that had resulted in 11 observations.

The facility, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma, was inspected by the US regulator from March 24 to April 10, 2025. The inspection covered the plant’s manufacturing operations for inhalers, dermatology and transdermal products.

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The US FDA had issued a Form 483 with 11 observations at the conclusion of the inspection. The company has now received the Establishment Inspection Report (EIR), which classified the facility as VAI and confirmed that the inspection has been closed.

The VAI classification is significant for Aurobindo Pharma as applications for multiple inhalers and other dosage forms manufactured at the facility can now progress through the US FDA’s review process, the company said in a regulatory filing.

A VAI classification indicates that the regulator has identified objectionable conditions or practices but does not currently intend to recommend regulatory action based on the inspection findings.

The Raleigh facility is part of Aurobindo Pharma’s US operations and is focused on complex and specialised dosage forms, including inhalation, dermatology and transdermal products.