“US FDA had inspected the company’s manufacturing plant situated at Silvassa, Dadra and Nagar Haveli and had identified certain deficiencies on account of data integrity and maintenance lapses. Upon conclusion of the inspection, the Company had received inspectional observations to which responses were suitably submitted to the US FDA,” according to a stock exchange filing.
The company informed that the United States Food and Drug Administration issued the import alert on June 10, 2026, after reviewing the company’s responses and the Establishment Inspection Report (EIR) arising from the inspection.
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According to Dabur, the United States Food and Drug Administration had inspected the Silvassa plant and identified certain deficiencies on account of data integrity and maintenance lapses. Following the inspection, the company received inspectional observations and submitted responses to the regulator.
Dabur said the import alert applies to drugs manufactured at the concerned part of the facility. The company stated that there are no violations or contraventions committed or alleged to have been committed in connection with the order.
The company added that the order does not have any impact on its financial, operational or other business activities. It said the matter relates only to a small part of the Silvassa manufacturing plant associated with private-label products that generate insignificant revenue for the company.
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Dabur further stated that domestic products are not covered by the order and remain unaffected. The Silvassa facility continues to operate, it said. The company said it is continuing to engage with the United States Food and Drug Administration by providing corrective and preventive action plans and implementing measures to address the identified gaps.
Further, it said, “We are continuing to engage with the US FDA authority by providing corrective and preventive action plans along with proactive and strong action on the ground to fix the identified gaps. In addition, multiple internal and external independent third-party testing has shown no out-of-specification or any other concerns with any of the company’s products.”
“We remain committed to product quality and consumer safety despite this one-off incident. We operate sites across the globe and are taking effective action to implement alternative sourcing strategies for our US customers. There is no material delay on the part of the company, as the company was reviewing the order and evaluating next steps in the matter,” Dabur India added.
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Shares of Dabur India Ltd ended at ₹422.20, down by ₹5.65, or 1.32%, on the BSE.
(Edited by : Jomy Jos Pullokaran)
