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FDA Flags Dabur India Plant for Data Lapses
11 Jun
Summary
- FDA issued an import alert for drugs from Dabur India's factory.
- Inspection revealed data integrity and maintenance lapses.
- Bird droppings were found in the company's raw material warehouse.
The U.S. Food and Drug Administration (FDA) has placed an import alert on drugs from Dabur India's manufacturing facility located in Dadra and Nagar Haveli. This regulatory action was initiated after an FDA inspection uncovered significant lapses concerning data integrity and facility maintenance.
Inspection reports indicated that critical manufacturing records were falsified to conceal the improper use of equipment. The FDA also noted unsanitary conditions, including the discovery of bird droppings within the raw material warehouse. Products subject to an FDA import alert can face detention.
Dabur India, a prominent consumer goods company, asserts that the import alert does not affect its operations or finances. The company is actively engaged with the FDA, providing corrective action plans to address the identified deficiencies. Domestic product sales remain unaffected by this regulatory action.
