Aurobindo Pharma announced that its subsidiary, Apitoria Pharma Pvt Ltd, has received an Establishment Inspection Report (EIR) from the US FDA for its Unit-V API manufacturing facility in Telangana.

The inspection, conducted between December 1 and December 12, 2025, had concluded with the issuance of a Form 483 with three observations.

The US FDA has now classified the facility under “Voluntary Action Indicated” (VAI) and officially closed the inspection, indicating no further regulatory action at this stage.