US FDA Issues Import Alert Against Dabur's Plant over Data Integrity Lapses

The US Food and Drug Administration has issued an import alert for drugs manufactured at Dabur India's factory in Dadra and Nagar Haveli, following an inspection, the consumer goods company said through stock filing on Thursday.

"US FDA had inspected Company's manufacturing plant situated at Silvassa, Dadra and Nagar Haveli and had identified certain deficiencies on account of data integrity and maintenance lapses," Dabur said.

Last month, Reuters had reported, citing the inspection report, that the regulator found critical manufacturing records were falsified to conceal that equipment meant for certain products had been used for multiple other products. A live bird and bird droppings were also found in the raw material warehouse, about 30 feet from packaging materials.

A product placed on an FDA import alert can be detained without physical examination unless the importer demonstrates that it has addressed the violations cited in the alert.

Dabur describes itself as one of India's oldest and largest consumer goods companies and one of the world's largest suppliers of Ayurvedic products, with a legacy of over 140 years. It sells a range of over-the-counter and consumer health products in the United States, including cough and cold rubs, antifungal creams, pain relief gels and oral care products.

No Financial or Operational Impact

The company said the FDA action would not have any financial or operational impact, adding that domestic products are not affected by the order.

"There is no impact on financial, operation or other activities of the Company due to this order. The order concerns to only a small part of our manufacturing plant situated at Silvassa, Dadra and Nagar Haveli, in relation to private label products, which generates insignificant revenue for the Company. Domestic products are not covered and not impacted by this order. The aforesaid plant continues to be operational," the company added.

Dabur said it continues to engage with the US regulator by providing "corrective and preventive action plans," along with taking steps to fix the identified gaps.