US FDA slaps import alert on Dabur's Dadra plant over data integrity and sanitation lapses
The US drug regulator flagged falsified records, data integrity gaps, and sanitation failures at Dabur India's Dadra and Nagar Haveli facility, triggering an import alert. Dabur says no financial or operational hit, domestic products unaffected, and corrective action plans have been submitted to the FDA.
What happened
Dabur India · US FDA issued an import alert on drugs made at Dabur's Dadra and Nagar Haveli plant after inspection flagged data integrity, falsified records,
Key facts
- 140 years
- 30 feet
Why this matters
The import alert weakens Dabur's US OTC optionality and could open negotiating room on any pending US distribution or co-manufacturing deals until the facility is cleared.