Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.
The FDA has imposed an import alert against Dabur India, positioning authorities to detain shipments of products manufactured at one of the company’s facilities.
The sanction follows an inspection that identified a live bird and bird droppings, an unidentified black substance and inaccurate laboratory data and production records, among other concerns. Inspectors also accused plant staff of attempting to conceal the issues.
Dabur is an Indian consumer goods company that sells over-the-counter medicines such as cough syrups. The FDA import alert against a Dabur plant in western India lists antibiotics, dietary supplements and other drugs among the types of products that authorities could detain. Dabur disclosed the import alert in a notice to investors on Thursday.
The FDA imposed the import alert months after its inspectors visited the Dabur facility. FDA inspectors identified “certain deficiencies on account of data integrity and maintenance lapses,” Dabur said. After receiving the inspectors’ observations, Dabur submitted responses to the FDA.
However, the responses failed to spare Dabur from sanction. The import alert will have no financial or operational impact on Dabur, the company said. Calling the issues at the plant a “one-off incident,” Dabur said it is taking “effective action to implement alternate sourcing strategies” for its U.S. customers.
The alert only applies to a small part of the facility that makes private label products, which generate “insignificant revenue,” Dabur said. The company continues to make products for the Indian market at the plant.
Dabur is engaging with the FDA “by providing corrective and preventive action plans along with proactive and strong action on the ground to fix the identified gaps,” the company said. Multiple tests by Dabur and third parties have found no out-of-specification results or other concerns with the affected products, the company said.
FDA inspectors found fault with many aspects of the plant when they visited in January, leading them to issue a nine-page Form 483. The “maintenance lapses” referenced by Dabur included the discovery of a live bird and bird droppings in a raw material warehouse. An “apparent unidentified black substance” covered about 25% of the ceiling of Dabur’s raw material and finished product warehouses, the FDA said.
The Form 483 described multiple data integrity issues. Inspectors called out inaccurate laboratory data and production records, plus missing physical evidence and documentation, in a six-point observation about the quality control unit’s oversight of production records.
During the inspection, Dabur “falsified critical manufacturing records by creating fraudulent equipment usage documentation designed to conceal multi-product manufacturing operations,” the FDA said. The company deliberately removed several U.S. products when creating a new equipment log, according to the inspectors, who said the products were recorded in the original logbook.
