June 11 (Reuters) – The U.S. Food and Drug Administration 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 said on Thursday.
The action was taken after the FDA inspected the factory and flagged data integrity and maintenance lapses.
Last month, Reuters reported citing the inspection report that the regulator found critical manufacturing records were falsified to conceal that equipment meant to make certain products had been used for multiple other products.
A live bird and bird droppings were 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 is one of India’s oldest and largest consumer goods companies, describing itself as 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.
The company said the FDA action does not have any financial or operational impact, adding that domestic products are not impacted by the order.
It said that it continues to engage with the U.S. regulator by providing “corrective and preventive action plans” along with taking actions to fix the identified gaps.
(Reporting by Nishit Navin in Bengaluru; Editing by Shailesh Kuber)
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