Dabur India Receives US FDA Warning Letter for Silvassa Plant

Dabur India Ltd has received a Warning Letter from the United States Food & Drug Administration (US FDA) concerning its manufacturing plant in Silvassa. The letter follows an inspection that identified gaps in data integrity and maintenance. The US FDA had previously issued an Import Alert (IA) 66-40 on June 10, 2026, for drugs manufactured at this plant. Dabur India has been actively engaging with the US FDA, providing updates on its corrective and preventive action plan, with substantial mitigating actions already completed, including data integrity training and infrastructure gap closure. The issue pertains to a small part of the plant related to private label product exports, which do not generate significant revenue, and domestic products remain unaffected. The plant continues to operate for the domestic market.