US FDA Imposes Import Alert For Drugs Manufactured At Dabur India's Silvassa Plant

The US Food and Drug Administration issued an import alert on 10 June 2026 for drugs manufactured at Dabur India's plant in Silvassa, Dadra and Nagar Haveli.

An inspection flagged data integrity violations and maintenance failures serious enough to include falsified manufacturing records and a live bird found in a raw material warehouse.

Dabur disclosed the action in an exchange filing on 11 June. The company said the US Food and Drug Administration issued Import Alert 66-40 following a review of its inspection responses and the Establishment Inspection Report from the Silvassa facility.

Dabur shares traded broadly flat on 12 June, opening at ₹422.15 against the previous close of ₹422.20. The stock hit an intraday high of ₹429, before trading at ₹423, up 0.30% at 12:20 PM.

What The Inspection Found

The findings from the inspection were significant:

• Critical manufacturing records were falsified to conceal that equipment meant for specific products had been used for multiple other products.

• A live bird and bird droppings were found in the raw material warehouse, approximately 30 feet from packaging materials.

• Data integrity and maintenance lapses were flagged across the facility.

Under an import alert of this nature, products from the affected plant can be detained at the US border without physical examination unless the importer demonstrates that the cited violations have been addressed.

Financial Impact And Company Response

Dabur said the order affects only a small portion of its Silvassa manufacturing plant, which generates insignificant revenue for the company. Domestic products are not covered by the alert and the plant continues to operate. The company said the impact on its financials, operations or other activities is nil.

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The company said it is actively engaging with the US Food and Drug Administration by submitting corrective and preventive action plans and taking steps to fix the identified gaps. Dabur said it is also implementing alternate sourcing strategies for its US customers.

Dabur sells a range of over-the-counter and consumer health products in the United States.

Sources:

Livemint

Business Standard