The US Food and Drug Administration (FDA) has issued an Import Alert (IA 66-40) for drugs manufactured at a section of Dabur India’s plant in Silvassa, Dadra and Nagar Haveli, following an inspection that flagged serious regulatory lapses, according to financial media reports.
According to the reports, the US regulator noted that critical manufacturing records were allegedly falsified to conceal that equipment intended for specific products was being used across multiple other products.
Inspection findings also reportedly revealed poor warehouse conditions, including a microbiological contamination risk highlighted by the discovery of a live bird and bird droppings roughly 30 feet from packaging materials.
The plant’s management reportedly skipped essential reviews of production records before releasing certain product batches to the market.
Under this alert, US authorities can detain targeted shipments from the facility without physical examination. The affected product segment consists primarily of private-label over-the-counter (OTC) items such as cough rubs, antifungal creams, and pain relief gels.
Dabur India clarified in its stock exchange filings that the impact is limited to a small section of the plant, with the affected exports accounting for less than 1% of the group’s total consolidated revenue.
The import alert does not cover or impact any products sold within India, and the Silvassa facility remains fully operational for other segments.
