Sun Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration (FDA) has assigned an “Official Action Indicated” (OAI) status to its Baska manufacturing facility following a recent regulatory inspection.

The OAI classification indicates that the FDA observed certain issues during the inspection that require corrective action. However, the company clarified that manufacturing operations and supplies to the U.S. market from the Baska facility will continue without disruption.

In a regulatory filing, Sun Pharma stated that it is engaging with the FDA to address the observations and ensure full compliance with applicable regulatory requirements. While an OAI outcome reflects more significant concerns than routine inspection findings, it does not automatically lead to a suspension of operations.