DABUR2026-08-07DABUR2026-08-07ActionsTakenOrOrdersPassedDomain1DABUR2026-08-07ActionsTakenOrOrdersPassedDomain1PersonsAgainstWhomActionsTakenOrOrdersPassedDomain1DABUR2026-08-07SignatoriesDomain1xbrli:pureDABURDabur India Limited500096NOTLISTEDINE016A01026NewAction(s) taken or orders passed (sub-para 20)false2026-07-2422:03:002026-08-07Warning or CautionRegulatory AuthorityUnited States Food and Drug Administration (US FDA)1Listed Entity (Self)Dabur India LimitedWarning NoticeAs informed earlier vide our letters dated June 1, 2026 and June 11, 2026, US FDA had inspected Company’s manufacturing plant situated at Silvassa, Dadra and Nagar Haveli and had identified certain gaps on account of data integrity and maintenance lapses. Pursuant to observations noted by the authority, review of the Company’s responses and Establishment Inspection Report (EIR), US FDA had issued an Import Alert (IA) 66-40 on June 10, 2026 (received by the company via email), for drugs manufactured by the Company at the aforesaid plant. An intimation in this regard was filed with stock exchanges on June 11, 2026. Now, the Company is in receipt of a Warning Letter which summaries all above information and events. Issuing warning letter is a continuous part of the actions taken by US FDA post their audits. As part of the continuing engagement, US FDA has sought additional details regarding the corrective and preventive action plan. It is submitted that the Company has maintained proactive and transparent engagement with the US FDA, providing regular progress updates on remediation activities. The Company has since provided four detailed progress updates in line with agreed timelines. To date, substantial parts of Company’s mitigating actions have already been completed. Such actions 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 & controls to strengthen governance and prevent recurrence of identified gaps, closure of all observed infrastructure related gaps within 30 days. Also, a comprehensive retrospective risk assessment of impacted processes, systems and products have been completed. The Company has also engaged a reputed independent US-based compliance consulting firm to support assessment, implementation and verification of corrective actions, with a focus on ensuring sustainable and effective closure of all identified gaps. To further strengthen the remedial action plan and respond to US FDA queries, revised response was submitted and company is working to close the actions in committed timelines and has been sharing regular updates with US FDA. 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. Domestic products are not covered and not impacted by this. The aforesaid plant continues to be operational for domestic market. The Company remains fully committed to working closely with the US FDA and completing the remaining actions in accordance with regulatory expectations.2026-07-24As informed earlier vide our letters dated June 1, 2026 and June 11, 2026, US FDA had inspected Company’s manufacturing plant situated at Silvassa, Dadra and Nagar Haveli and had identified certain gaps on account of data integrity and maintenance lapses. Pursuant to observations noted by the authority, review of the Company’s responses and Establishment Inspection Report (EIR), US FDA had issued an Import Alert (IA) 66-40 on June 10, 2026 (received by the company via email), for drugs manufactured by the Company at the aforesaid plant. An intimation in this regard was filed with stock exchanges on June 11, 2026. Now, the Company is in receipt of a Warning Letter which summaries all above information and events. Issuing warning letter is a continuous part of the actions taken by US FDA post their audits. As part of the continuing engagement, US FDA has sought additional details regarding the corrective and preventive action plan. It is submitted that the Company has maintained proactive and transparent engagement with the US FDA, providing regular progress updates on remediation activities. The Company has since provided four detailed progress updates in line with agreed timelines. To date, substantial parts of Company’s mitigating actions have already been completed. Such actions 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 & controls to strengthen governance and prevent recurrence of identified gaps, closure of all observed infrastructure related gaps within 30 days. Also, a comprehensive retrospective risk assessment of impacted processes, systems and products have been completed. The Company has also engaged a reputed independent US-based compliance consulting firm to support assessment, implementation and verification of corrective actions, with a focus on ensuring sustainable and effective closure of all identified gaps. To further strengthen the remedial action plan and respond to US FDA queries, revised response was submitted and company is working to close the actions in committed timelines and has been sharing regular updates with US FDA. 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. Domestic products are not covered and not impacted by this. The aforesaid plant continues to be operational for domestic market. The Company remains fully committed to working closely with the US FDA and completing the remaining actions in accordance with regulatory expectations.Not applicableThere is no impact on financial, operation or other activities of the Company due to this warning notice. The warning notice concerns to 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 domestic market. 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 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.There is no violation(s)/contravention(s) committed or alleged to be committed. The US FDA warning letter is a continuous part of the actions taken by US FDA post their audits. As part of the continuing engagement, US FDA has sought detailed corrective and preventive action plan. We will be responding to this warning letter in due prescribed timelines as part of our mitigating actions i.e. within 15 working days of receipt of notice. This is a serious matter and we are approaching a resolution as desired by the US FDA with utmost urgency and gravity that it deserves.There is no violation(s)/contravention(s) committed or alleged to be committed. The US FDA warning letter is a continuous part of the actions taken by US FDA post their audits. As part of the continuing engagement, US FDA has sought detailed corrective and preventive action plan. We will be responding to this warning letter in due prescribed timelines as part of our mitigating actions i.e. within 15 working days of receipt of notice. This is a serious matter and we are approaching a resolution as desired by the US FDA with utmost urgency and gravity that it deserves.As aboveWe 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 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.Ashok Kumar JainCompliance Officer2026-08-07New Delhi