Intimation of classification of Unit VII of the Company by US FDA as Voluntary Action Indicated (VAI)
AUROPHARMA · price
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US FDA inspected Aurobindo Pharma's Unit-VII (oral solid dosage manufacturing unit in Jedcherla, Telangana) from January 28 to February 10, 2026. A Form 483 was issued with 9 observations at the end of the inspection. The facility has now received an Establishment Inspection Report (EIR) classifying it as 'Voluntary Action Indicated' (VAI), which is the mildest FDA classification. FDA has concluded the inspection is now closed. This means the FDA found some compliance deviations but is not requiring formal enforcement action — the company is expected to take voluntary corrective measures.
VAI is a relatively mild outcome with no formal enforcement action; the unit remains operational and the inspection is closed, which removes near-term regulatory uncertainty for investors.