Aurobindo Pharma’s Unit-IV receives VAI classification from US FDA

Business Desk — Thu, 12 Mar 2026 04:19:04 +0000

Aurobindo Pharma’s Unit-IV, part of APL Healthcare Limited, has been classified as ‘Voluntary Action Indicated’ (VAI) by the US FDA, marking the closure of its recent inspection.

The inspection of Unit-IV, located in Andhra Pradesh, was conducted by the United States Food and Drug Administration (US FDA) from December 8 to December 17, 2025. Following the inspection, a ‘Form 483’ was issued with five observations. The recent Establishment Inspection Report (EIR) now categorises the facility as VAI, indicating that the inspection is officially closed.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

APL Healthcare | Business Upturn

Aurobindo Pharma’s Unit-IV receives VAI classification from US FDA