Key facts
- The US FDA issued an import alert for drugs manufactured at Dabur India's Silvassa plant.
- The alert cites data integrity and maintenance lapses identified during an inspection.
- Inspection reports noted falsified manufacturing records and unsanitary conditions.
- Dabur India stated the alert has a limited impact on operations and does not affect domestic sales.
- The company is submitting corrective action plans to the FDA.
The US Food and Drug Administration (FDA) has issued an import alert for drugs manufactured at Dabur India's plant in Silvassa, Dadra and Nagar Haveli. The action follows an inspection that identified deficiencies related to data integrity and maintenance lapses. Reports indicated that critical manufacturing records were allegedly falsified to conceal equipment usage for multiple products, and unsanitary conditions were found, including a live bird in a raw material warehouse. Dabur India stated that the import alert affects only a small portion of its operations concerning private label products with insignificant revenue generation. The company emphasized that its domestic products are not impacted and the plant remains operational. Dabur is actively engaging with the FDA by submitting corrective and preventive action plans to address the identified issues, asserting its commitment to product quality and consumer safety.