Mumbai, Aug. 17 -- The facility, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma, manufactures inhalers, dermatology and transdermal products. The USFDA had inspected the facility from 24 March 2025 to 10 April 2025 and issued Form 483 with 11 observations at the conclusion of the inspection.

The company has now received the Establishment Inspection Report (EIR), which classified the facility as "Voluntary Action Indicated" (VAI). The USFDA has concluded and closed the inspection.

With the facility receiving a VAI classification, pending applications for multiple inhalers and other dosage forms manufactured at the facility can now progress through the USFDA's review process.

Aurobindo Pharma is eng...