The Food and Drug Administration has imposed an import alert against Dabur India, allowing authorities to detain shipments of products manufactured at one of the company’s facilities, according to a June 12 notice. The action follows an inspection that uncovered a live bird and bird droppings, an unidentified black substance, inaccurate laboratory data, and production records, among other concerns. Inspectors also said plant staff attempted to conceal these issues.
Dabur India is a consumer goods company that sells over-the-counter medicines such as cough syrups. The FDA's import alert against its western India plant includes antibiotics, dietary supplements, and other drugs among the types of products subject to detention. Dabur disclosed the import alert in a notice to investors.
The FDA issued the sanction months after inspectors visited the facility. According to Dabur, inspectors identified “certain deficiencies on account of data integrity and maintenance lapses.” After receiving observations from the FDA inspectors, Dabur submitted responses but was still sanctioned. The company said in its investor notice that the import alert will have no financial or operational impact on Dabur, and described the situation as a “one-off incident.” It added it is taking “effective action to implement alternate sourcing strategies” for U.S. customers.
Dabur stated that only a small part of the facility making private label products—which generate “insignificant revenue”—is affected by this action. Production for the Indian market continues at the same plant.
Dabur said it is engaging with U.S. regulators by providing corrective and preventive action plans while conducting proactive measures onsite to address identified gaps. The company reported multiple tests by itself and third parties found no out-of-specification results or other concerns with affected products.
During their January visit, FDA inspectors issued a nine-page Form 483 citing maintenance lapses including discovery of a live bird in raw material storage areas and an unidentified black substance covering about 25% of certain warehouse ceilings. Inspectors also cited multiple data integrity issues such as inaccurate laboratory data, missing documentation in production records, falsified manufacturing records designed to conceal multi-product operations, and deliberate removal of several U.S.-bound products from equipment logs.
