Federal health regulators have blocked drug imports from a Dabur India manufacturing facility following a recent inspection that uncovered serious safety violations, the company announced Thursday.
The U.S. Food and Drug Administration took action against the plant located in India’s western Dadra and Nagar Haveli region after discovering problems with data integrity and facility maintenance during their review.
According to a Reuters report from last month citing the inspection findings, investigators discovered that crucial manufacturing documentation had been falsified to hide the fact that equipment designated for specific products was being used to make multiple different items.
Inspectors also discovered unsanitary conditions at the facility, including a live bird and bird waste in the raw materials storage area, located approximately 30 feet away from packaging supplies.
Under FDA import alert procedures, any product from the flagged facility can be held at the border without physical inspection unless the importing company proves it has resolved the cited violations.
Dabur India represents one of the country’s most established and largest consumer goods manufacturers, billing itself as a leading global provider of Ayurvedic products with more than 140 years in business. The company markets various over-the-counter and health products in the United States, including treatments for coughs and colds, antifungal medications, pain relief products, and oral care items.
Company officials stated that the FDA’s action will not create financial or operational consequences, noting that products sold domestically remain unaffected by the restriction.
The manufacturer indicated it is working with U.S. regulators by submitting “corrective and preventive action plans” while implementing measures to address the identified problems.
