Aurobindo Pharma has announced that the United States Food and Drug Administration (USFDA) has completed an inspection of the Raleigh Plant in North Carolina, USA, owned by Aurolife Pharma, a wholly owned step-down subsidiary of the company. The facility received a Form 483 containing 11 observations.
The plant was established for the manufacture of inhalers, dermatology products and transdermal products. The inspection was conducted from March 24 to April 10, 2025.
The facility has now received the Establishment Inspection Report (EIR), classifying it as “Voluntary Action Indicated” (VAI). The USFDA has concluded the inspection and closed the inspection process.
A VAI classification indicates that objectionable conditions or practices were identified during the inspection, but the agency is not prepared to take or recommend any administrative or regulatory action.
With the unit classified as VAI, Aurobindo Pharma said pending applications for multiple inhalers and other dosage forms manufactured at the facility can now progress through the USFDA’s review process.
