Aurobindo Pharma has received official notice that its Unit-VII manufacturing facility in Jedcherla, Telangana, has been classified as Voluntary Action Indicated (VAI) by the US FDA. This follows a comprehensive inspection conducted between January 28 and February 10, 2026. With the issuance of the Establishment Inspection Report (EIR), the regulatory review for this facility is now officially closed.
Successful Inspection Outcome
Aurobindo Pharma’s Unit-VII, an oral solid dosage manufacturing facility located in the Special Economic Zone at Jedcherla, has successfully navigated its recent US FDA inspection. The regulatory body has concluded its review of the site, which was inspected over a two-week period in early 2026.
Understanding the VAI Classification
Following the inspection, which initially identified 9 observations in a ‘Form 483’, the company has worked to address regulatory requirements. The current Voluntary Action Indicated (VAI) classification indicates that the US FDA has found the facility’s response and corrective actions satisfactory. The agency has officially closed the inspection, confirming that the unit remains in good standing for its ongoing pharmaceutical manufacturing operations.
Source: BSE
