FDA Detains Dabur India Drugs Over Bird Droppings, Faked Records

The US Food and Drug Administration has blocked drugs made at a Dabur India factory in Dadra and Nagar Haveli after inspectors found bird droppings in a raw material warehouse and falsified manufacturing records, the company disclosed Thursday.

The import alert covers drugs from that plant. A product placed on alert can be detained without physical examination unless the importer proves the violations are fixed.

Dabur said the action has no financial or operational impact and that domestic products are not affected. The company continues to engage with the FDA through corrective action plans, it said.

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The FDA inspected the factory and flagged data integrity issues and maintenance lapses. Reuters reported last month, citing the inspection report, that critical manufacturing records had been falsified to hide that equipment meant for certain products had been used for multiple others. A live bird and bird droppings were found about 30 feet from packaging materials in the raw material warehouse, according to the report.

Dabur, one of India's oldest consumer goods companies, describes itself as one of the world's largest suppliers of Ayurvedic products with a 140-year legacy. It sells over-the-counter and consumer health products in the US including honey, hair oil, cough and cold rubs, antifungal creams, pain relief gels, and oral care items.

The import alert applies specifically to drugs manufactured at the Dadra plant. OTC products like honey and hair oil are not covered under the same alert regime, though the FDA classification of what constitutes a drug for import purposes is broad.