Dabur India Limited on Thursa said the United States Food and Drug Administration has issued an import alert on drugs manufactured at a portion of its Silvassa facility, citing deficiencies related to data integrity and maintenance practices.
“US FDA had inspected Company’s manufacturing plant situated at Silvassa, Dadra and Nagar Haveli and had identified certain deficiencies on account of data integrity and maintenance lapses,” Dabur India Limited said in its exchange filing.
In a regulatory filing, Dabur said the import alert (IA 66-40), issued on June 10, 2026, follows an inspection of the company’s manufacturing plant in Silvassa, Dadra and Nagar Haveli.
The company clarified that the order pertains only to a limited part of the company’s manufacturing plant situated at Silvassa, Dadra and Nagar Haveli, in relation to private label products, which generates insignificant revenue for the Company.
Dabur added that the Silvassa plant continues to remain operational and that there are no violations or contraventions alleged against the company. It is currently engaging with the US FDA by providing corrective and preventive action plans along with proactive and strong action on the ground to fix the identified gaps.
“In addition, multiple internal and external independent third party testing has shown no out of specification or any other concerns with any of Company’s products,” they added.
Dabur has also confirmed taking effective action to implement alternate sourcing strategies for our US customers.
