- The US FDA flagged serious manufacturing and data integrity lapses at Dabur's plant in Dadra and Nagar Haveli
- The FDA report cited contamination risks and poor equipment cleaning and maintenance at the facility
- Inspectors found a live bird and droppings near raw materials close to packaging areas
At a time when Indian pharmaceutical and healthcare product manufacturers are facing increased scrutiny from US regulators over quality standards and manufacturing practices, the US Food and Drug Administration (FDA) has flagged serious manufacturing, maintenance and data integrity lapses at a Dabur India plant.
The regulator identified multiple deficiencies at the plant located in Dadra and Nagar Haveli, raising concerns over potential microbiological contamination and compliance with manufacturing standards.
According to the FDA report, certain units within the facility posed contamination risks, while inspectors observed lapses in equipment cleaning, maintenance and quality control procedures.
The agency also alleged that critical manufacturing records had been falsified to conceal the use of equipment for products other than those for which it was designated.
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Among the observations highlighted in the report were the presence of a live bird and bird droppings inside a raw material warehouse situated close to packaging materials.
Inspectors also reported spotting an unidentified black substance covering significant portions of the ceiling surfaces in both raw material and finished product storage areas.
The FDA further questioned the reliability of microbiological testing conducted at the facility.
While official test records indicated that samples met prescribed limits, inspectors reportedly observed significant contamination in several samples during the inspection process.
The report also noted that management had failed to adequately review production and quality records before releasing batches to the market, potentially compromising compliance with regulatory requirements.
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Dabur, one of India's oldest consumer goods companies and a major supplier of Ayurvedic and over-the-counter healthcare products in the US market, did not immediately respond to Reuters' request for comment.
Companies receiving an FDA Form 483 typically submit corrective action plans to address the observations raised by inspectors.
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