Dabur India in its response to the warning letter issued by the US Food and Drug Administration (US FDA) has said that it will have no material impact on its financial or operational performance, as it relates only to a small part of its Silvassa manufacturing facility that produces private label products for export to the US.
In a stock exchange filing, the company said the warning concerns only a limited section of its plant in Silvassa, Dadra and Nagar Haveli, which manufactures private-label products for export and does not generate significant revenue. It added that its domestic products are not covered by the warning and the facility continues to operate for the domestic market.
“The US FDA warning letter is a continuous part of the actions taken by US FDA post their audits,” Dabur said, adding that the regulator has sought a detailed corrective and preventive action (CAPA) plan. The company said it will respond to the warning letter within the prescribed timeline of 15 working days and is treating the matter with “utmost urgency and gravity”.
Corrective Actions
Dabur said it has been engaging with the US FDA by submitting detailed corrective and preventive action plans and taking proactive steps to address the identified gaps. It also said multiple internal and independent third-party tests have shown no out-of-specification results or other concerns with any of its products.
The company said it has implemented alternate sourcing strategies for its US customers and engaged a reputed US-based compliance consulting firm to support the assessment, implementation and verification of corrective actions. It added that it has already submitted a revised response to the US FDA and continues to share regular updates with the regulator while working to complete the remaining corrective actions within committed timelines.
Key Findings
The disclosure comes after the US FDA, in a warning letter dated July 24, cited serious current Good Manufacturing Practice (CGMP) violations at Dabur’s Silvassa facility. The regulator alleged that the company’s quality unit failed to adequately oversee manufacturing operations and ensure the integrity of production records.
It also flagged a falsified equipment usage logbook, discrepancies between laboratory source data and batch manufacturing records, and said Dabur’s response to the inspection findings did not adequately address what it described as systemic shortcomings in quality oversight and data integrity.