Dabur India has received a Warning Letter from the US Food & Drug Administration (US FDA) concerning data integrity and maintenance lapses identified at its manufacturing plant in Silvassa. While the issue pertains to a small segment of export-only private label products, not generating significant revenue and not affecting domestic sales, the company is proactively engaged in remediation. Domestic operations at the plant continue uninterrupted. The company is working closely with the US FDA to address the identified gaps and has provided several progress updates.
US FDA Issues Warning Letter to Dabur India
Dabur India Limited has been issued a Warning Letter by the United States Food & Drug Administration (US FDA) following an inspection of its manufacturing plant located in Silvassa, Dadra and Nagar Haveli. The letter addresses identified gaps related to data integrity and maintenance lapses, stemming from an inspection earlier in the year.
Background and Context
The US FDA had previously issued an Import Alert (IA) 66-40 on June 10, 2026, for drugs manufactured at the Silvassa facility, a development previously disclosed to stock exchanges. The Warning Letter signifies a continuous part of the US FDA’s post-audit actions. The authority has requested detailed information on the company’s corrective and preventive action plan. Dabur India is committed to responding to this warning letter within the stipulated 15 working days.
Company’s Remediation Efforts
Dabur India stated that it has maintained a proactive and transparent engagement with the US FDA, providing regular updates on its remediation activities. The company reports that substantial portions of its mitigating actions are complete. These actions include comprehensive data integrity training for all manufacturing operations personnel and the deployment of an additional independent resource for continuous oversight. Furthermore, all observed infrastructure-related gaps have been addressed within 30 days, and a retrospective risk assessment of impacted processes, systems, and products has been concluded. Dabur has also engaged an independent US-based compliance consulting firm to support the assessment and implementation of corrective actions.
Impact on Operations and Revenue
The company emphasized that the issue concerns only a small part of its manufacturing plant related to the export of private label products, which do not generate significant revenue for Dabur India. Domestic products manufactured at the Silvassa plant are not covered by this action and remain unaffected. The plant continues to operate for the domestic market without disruption. Dabur India is implementing alternate sourcing strategies for its US customers and has confirmed that multiple internal and external third-party tests have shown no out-of-specification results or other concerns with its products.
Disclosure Timeline
The Warning Letter was received by the Company on July 24, 2026, at 10:03 p.m. Dabur India stated there was no material delay in disclosure, as the company was reviewing the notice with internal and external stakeholders to determine the next steps. This information is being made available on the company’s website, www.dabur.com.
Source: BSE
