The company said the warning letter follows the US FDA inspection of the facility, during which the regulator had identified certain gaps related to data integrity and maintenance lapses. Following the observations, the US FDA had issued an Import Alert (IA) 66-40 on June 10, 2026, for drugs manufactured by the company at the Silvassa plant.
Dabur said the warning letter summarises the earlier information and actions taken by the regulator after the inspection. The company added that the issuance of the warning letter is part of the continuing engagement process with the US FDA, and the regulator has sought additional details regarding the corrective and preventive action plan.
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“The US FDA warning letter is a continuous part of the actions taken by the US FDA post their audits. As part of the continuing engagement, the US FDA has sought a detailed corrective and preventive action plan,” Dabur said in its regulatory filing.
The company said it has maintained proactive engagement with the regulator and has provided regular updates on remediation activities. Dabur said it has submitted four detailed progress updates to the US FDA in line with agreed timelines.
The company said several corrective measures have already been completed. These include data integrity training across the entire manufacturing operations, deployment of an additional independent resource responsible for continuous review, oversight and monitoring of data integrity systems and controls, closure of infrastructure-related gaps within 30 days, and completion of a comprehensive retrospective risk assessment of impacted processes, systems and products.
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Dabur said it has also appointed an independent US-based compliance consulting firm to support the assessment, implementation and verification of corrective actions. It said, “To further strengthen the remedial action plan and respond to US FDA queries, a revised response was submitted, and the company is working to close the actions in committed timelines and has been sharing regular updates with the US FDA.”
It clarified that the issue is limited to a specific portion of its Silvassa facility and does not cover its domestic product portfolio. “It is pertinent to note that the issue concerns only a small part of our manufacturing plant situated at Silvassa in relation to export of private label products, which does not generate significant revenue for the Company,” Dabur said.
The company added that domestic products are not covered under the US FDA action and that the Silvassa facility continues to operate for the domestic market. “Domestic products are not covered and not impacted by this order. The aforesaid plant continues to be operational for the domestic market,” the company said.
Dabur further stated that the warning notice does not have any financial or operational impact on the company. “There is no impact on financial, operational or other activities of the company due to this warning notice.
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The warning notice concerns only a small part of our manufacturing plant situated at Silvassa, Dadra and Nagar Haveli, in relation to export of private label products, which does not generate significant revenue for the company. Domestic products are not covered and not impacted by this order. The aforesaid plant continues to be operational for the domestic market,” it said,
The company also said it has implemented alternate sourcing strategies for its US customers as part of its response plan. “We are continuing to engage with the US FDA authority by providing detailed 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. We have taken effective action to implement alternate sourcing strategies for our US customers,” Dabur said.
“There is no material delay on the part of the company as the company was reviewing the notice with multiple internal and external stakeholders and was evaluating next steps in the matter,” it added.
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