Hyderabad, Aug.17 (RAHNUMA): Aurobindo Pharma’s Raleigh facility in North Carolina has received a major regulatory boost after the US Food and Drug Administration (USFDA) classified its inspection as Voluntary Action Indicated (VAI) and closed the inspection.
The facility, operated by Aurolife Pharma LLC, manufactures inhalers, dermatology and transdermal products. The USFDA inspected the plant from March 24 to April 10, 2025, and issued a Form 483 containing 11 observations.
The company said it has now received the Establishment Inspection Report (EIR), with the facility classified as VAI.
The development will allow pending applications for multiple inhalers and other dosage forms manufactured at the facility to progress through the USFDA review process.
