Syngene’s Bengaluru facility clears US FDA inspection with VAI classification.

Syngene International Ltd, a leading contract research and manufacturing organization, announced on Friday (June 13) that it has obtained the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) after a routine inspection of its GMP manufacturing facilities located at Biocon Park, SEZ, Bengaluru.

The company stated, “We hereby inform you that we received the Establishment Inspection Report (EIR) from the USFDA via communication dated June 11, 2025. The EIR assessed the inspection outcome as Voluntary Action Indicated (VAI). The US FDA has reviewed and accepted our responses along with the Corrective and Preventive Action (CAPA) plans that were submitted in relation to the inspection findings.”

The inspection conducted from February 10 to 20 concluded with the classification of voluntary action indicated (VAI). Syngene noted that the FDA has reviewed and approved its responses alongside the CAPA plans submitted following the inspection.

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The company assured that it would keep the agency informed with periodic updates regarding the progress of its corrective actions. It also emphasized that the inspection outcome will not impact its finances or daily operations.

“Syngene will continue to provide timely updates to the USFDA concerning the progress of the corrective actions submitted. We are dedicated to upholding the highest standards of regulatory compliance and affirm that this outcome will not adversely affect the company’s financials or operations,” it added.

What is voluntary action indicated (VAI)?

VAI applies when violations are identified, but the issues do not warrant further regulatory action. In this scenario, improving GMP compliance is considered voluntary.

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The shares of Syngene International Ltd closed at ₹652.45, decreasing by ₹10.45, or 1.58%, on the BSE.