# Dabur Says Silvassa Plant Runs Despite USFDA Warning

2026-08-06T18:21:38+00:00 | Business & Economy | Indian Opinion Desk

Corroboration: 1 independent outlet

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the company voluntarily recalled selected products after a May 2026 discussion, but not all affected products had been withdrawn.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.

## Coverage

- livemint.com <https://www.livemint.com/companies/news/dabur-downplays-usfda-warning-says-india-business-unaffected-silvassa-plant-continues-operations-11786032407230.html>

Tags: Dabur, drug safety, pharmaceuticals, Silvassa, US FDA
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