Aurobindo Pharma Limited has announced that the United States Food and Drug Administration (USFDA) has classified its Raleigh plant in North Carolina, USA, as Voluntary Action Indicated (VAI) following an inspection conducted at the facility in 2025. The Raleigh plant is owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, and is established for the manufacturing of inhalers, dermatology and transdermal products.
The USFDA inspected the Raleigh plant from March 24, 2025, to April 10, 2025. At the end of the inspection, the USFDA issued a Form 483 containing a total of 11 observations.
Following the inspection, the facility has now received its Establishment Inspection Report (EIR) from the USFDA. The EIR has classified the facility as “Voluntary Action Indicated” (VAI). Aurobindo Pharma stated that the USFDA has concluded that the inspection is now closed.
The VAI classification follows the completion of the FDA's inspection process at the Raleigh facility. The company has stated that, with the facility classified as VAI, pending applications for multiple inhalers and other dosage forms filed from this facility can now progress through the USFDA’s review process.
The Raleigh facility is part of Aurobindo Pharma's operations in the United States and is specifically established for manufacturing inhalers, dermatology and transdermal products. The completion of the FDA inspection process and the VAI classification provide an important regulatory update concerning the facility and the applications associated with products manufactured at the site.
The company disclosed the development pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Aurobindo Pharma has requested that the information be taken on record.
Overall, the latest regulatory update confirms that the USFDA inspection of Aurobindo Pharma's Raleigh facility, which resulted in 11 observations on Form 483, has been concluded with the facility receiving a VAI classification through the Establishment Inspection Report. The company has also stated that pending applications for multiple inhalers and other dosage forms from the facility can now proceed through the USFDA review process.
