Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) inspected Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the company, established for manufacturing Inhalers, Dermatology and Transdermal products, from 24 March 2025 to 10 April 2025. At the end of inspection, form 483 was issued 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.
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. |