The United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned arm of Aurobindo Pharma for manufacturing Inhalers, Dermatology and Transdermal products,
The US regulator inspected the facility from March 24 to April 10, 2025 and issued Form 483 with a total of 11 observations.
The Unit has now received Establishment Inspection Report (EIR), classifying the facility as “Voluntary Action Indicated” (”VAI”). The USFDA has concluded that this inspection is now closed, and the Hyderabad-based company informed the BSE.
“As this unit is 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,” it said.
Published on August 17, 2026
