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US FDA issues warning letter to Dabur over Silvassa plant lapses
Company says domestic business unaffected as US regulator flags CGMP issues
MUMBAI: A bitter pill has landed in Dabur’s regulatory inbox. The FMCG major is facing tougher scrutiny from the US Food and Drug Administration, even as it insists the latest action affects only a small export-focused part of its business and leaves its India operations untouched.
Dabur India has received a warning letter from the US Food and Drug Administration (US FDA) following an inspection of its manufacturing facility in Silvassa, Dadra and Nagar Haveli, where regulators identified deficiencies related to data integrity, quality control and maintenance practices.
The warning follows a regulatory inspection conducted between 12 January and 16 January 2026 and represents an escalation after the facility was placed under Import Alert 66-40 in June 2026. The US regulator cited concerns over compliance with current good manufacturing practice (CGMP), quality systems and record-keeping processes at the site.
Seeking to reassure investors, Dabur said the observations relate only to a limited section of the Silvassa facility that manufactures private-label products for export to the US. The company said this business contributes only an insignificant share of its overall revenue and does not affect products sold in the domestic market.
In a regulatory filing, Dabur said the Silvassa plant continues to operate normally for the Indian market, adding that products sold domestically are not covered by the FDA’s action.
The company said the warning letter forms part of an ongoing engagement with the US regulator, which has requested further information on its corrective and preventive action plan. Dabur added that it has maintained regular communication with the FDA and has already submitted multiple progress reports detailing remediation measures.
According to the company, the corrective actions include comprehensive data integrity training across manufacturing operations, deployment of additional independent oversight, closure of infrastructure-related gaps and retrospective assessments of affected systems, processes and products. Dabur has also appointed a US-based compliance consulting firm to support its remediation programme.
Global Chief Executive Officer Mohit Malhotra said the company does not expect any material disruption to its operations, noting that part of the affected export production has already been shifted to its Baddi manufacturing facility as a precautionary measure.
The latest regulatory development comes shortly after Dabur faced scrutiny from India’s food safety regulator, which directed the company to discontinue certain “100 per cent natural” and “100 per cent pure” claims on select products, adding to a growing list of compliance challenges confronting the consumer goods maker.
