USFDA Issues Import Alert for Dabur India Plant After Quality Concerns

U.S. FDA Issues Import Alert for Dabur India's Factory in India's Dadra and Nagar Haveli Region

The U.S. Food and Drug Administration (FDA) has issued an import alert for drugs manufactured at Dabur India's factory in India's western region of Dadra and Nagar Haveli following an inspection. The consumer goods company, one of India's oldest and largest consumer goods companies with a legacy of over 140 years, announced the development on Thursday.

The action was taken after the FDA inspected the factory and flagged data integrity and maintenance lapses. According to an inspection report cited by Reuters last month, the regulator found critical manufacturing records were falsified to conceal that equipment meant to make certain products had been used for multiple other products. The report also revealed that a live bird and bird droppings were found in the raw material warehouse, approximately 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 India 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.