Aurobindo Pharma has announced that its Raleigh manufacturing facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC, has been classified as Voluntary Action Indicated (VAI) by the US Food and Drug Administration (FDA). The FDA has also concluded the inspection of the facility.

The Raleigh plant manufactures inhalers, dermatology products and transdermal products. The FDA inspected the facility between March 24 and April 10, 2025, following which it issued a Form 483 containing 11 observations.

Aurobindo Pharma said the facility has now received its Establishment Inspection Report (EIR), which classifies the inspection as VAI.

According to the company, the FDA has concluded the inspection following this classification.

The VAI classification is significant for the facility’s regulatory pipeline.

Aurobindo Pharma stated that pending applications for multiple inhalers and other dosage forms filed from the Raleigh facility can now progress through the FDA’s review process.  

The company disclosed the development in a regulatory filing dated August 17, 2026, under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.