USFDA classifies Aurobindo Pharma’s Raleigh plant as VAI

Aurobindo Pharma said 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 in 2025.

Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, the company said the USFDA inspected the Raleigh plant from March 24, 2025, to April 10, 2025. The facility is owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the company, and is established for manufacturing inhalers, dermatology and transdermal products.

At the end of the inspection, Form 483 was issued with a total of 11 observations.

The unit has now received the Establishment Inspection Report (EIR), which classifies the facility as “Voluntary Action Indicated” (VAI). The USFDA has concluded that the inspection is now closed.

The company said that as the unit is classified as VAI, pending applications for multiple inhalers and other dosage forms filed from the facility can now progress through the USFDA’s review process.

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