Aurobindo Pharma Limited has announced that its Raleigh manufacturing facility in North Carolina, USA, operated by Aurolife Pharma LLC, a wholly owned step-down subsidiary, has been classified as Voluntary Action Indicated (VAI) by the US Food and Drug Administration (USFDA).

The Raleigh facility manufactures inhalers, dermatology and transdermal products. The USFDA conducted an inspection of the facility from March 24 to April 10, 2025, following which the regulator issued a Form 483 containing 11 observations.

The company has now received the Establishment Inspection Report (EIR) from the USFDA, which classifies the facility as VAI. The regulator has also concluded and closed the inspection.

The VAI classification indicates that while the inspection identified issues requiring attention, the USFDA has not determined that regulatory action is currently warranted. The company said the classification has implications for pending applications relating to multiple inhaler products.

The development is significant for Aurobindo Pharma as the Raleigh facility is involved in manufacturing and development of complex products, including inhalation therapies. 

The closure of the inspection provides greater regulatory clarity for the facility and its pending product applications in the US market.