Now Reading: Dabur Says Silvassa Plant Runs Despite USFDA Warning
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Dabur Says Silvassa Plant Runs Despite USFDA Warning
Dabur India said its Silvassa pharmaceutical plant remains operational after the US Food and Drug Administration issued a warning over manufacturing deficiencies. The company said the action affects a small private-label operation…
The Story in Brief
Dabur India said its Silvassa pharmaceutical plant remains operational after the US Food and Drug Administration issued a warning over manufacturing deficiencies. The company said the action affects a small private-label operation that contributes insignificant revenue, with some production shifted to Baddi. The USFDA cited data integrity concerns, weak quality management, incomplete laboratory records and inadequate manufacturing controls following an inspection. It classified products from the facility as adulterated under US law and placed them under Import Alert 66-40, restricting US imports. Dabur has submitted a revised corrective-action response, including retraining staff and improving documentation and cleaning validation.
The regulator said Dabur’s initial response did not adequately address wider quality and data-integrity problems. It also said the company voluntarily recalled selected products after a May 2026 discussion, but not all affected products had been withdrawn. The USFDA advised appointing an independent consultant to review the plant’s practices.
The Indian Opinion
The easy narratives are that the warning either threatens Dabur’s entire business or is merely US regulatory overreach. Neither follows from the facts. Dabur says domestic operations are unaffected, but the USFDA’s findings on records, testing and validation are serious because they concern the reliability of manufacturing controls. The useful test is not the company’s reassurance. It is whether the independent review and follow-up inspection close the cited gaps, and whether every affected US batch is accounted for.
Source: livemint.com
This story was synthesised by AI from the source linked above.
