Aurobindo Unit Gets USFDA VAI Classification

New Delhi, Mar 12 (PTI) Aurobindo Pharma on Thursday said it has received an establishment inspection report with a satisfactory Voluntary Action Indicated (VAI) classification from the US health regulator for the Andhra-based manufacturing unit of its wholly-owned subsidiary.

As per the US Food and Drug Administration (USFDA), a VAI classification means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

The US Food and Drug Administration (USFDA) inspected Unit-IV of APL Healthcare Ltd in Nellore district from December 8-17, 2025.


At the end of the inspection, a Form 483 was issued with five observations.

"The unit has now received an Establishment Inspection Report (EIR) classifying the facility as Voluntary Action Indicated (VAI) and this inspection is now closed," the Hyderabad-based drugmaker said in a regulatory filing.

Aurobindo shares on Thursday ended 0.67 per cent up at Rs 1,313.30 apiece on the BSE.