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Personal Care
USFDA11 Jun 2026, 08:31 pm

Dabur India Faces US FDA Import Alert on Silvassa Plant

AI Summary

Dabur India Ltd has received an Import Alert (IA) 66-40 from the US FDA for drugs manufactured at its Silvassa plant, following an inspection that identified deficiencies in data integrity and maintenance. The company states there is no violation and no financial or operational impact, as the alert pertains to a small segment of private label products generating insignificant revenue. Domestic products are unaffected, and the plant remains operational. Dabur is engaging with the US FDA on corrective actions and exploring alternate sourcing for US customers.

Key Highlights

  • US FDA issued Import Alert 66-40 for Dabur's Silvassa plant drugs.
  • Deficiencies cited were data integrity and maintenance lapses.
  • Company claims no violation and no material financial impact.
  • Alert affects only a small portion of private label products.
  • Domestic products and plant operations remain unaffected.