US FDA flags manufacturing and data integrity lapses at Dabur India plant

New Delhi, May 31 (IANS) The US Food and Drug Administration (FDA) has flagged serious manufacturing, maintenance and data integrity lapses at a Dabur India manufacturing facility in Dadra and Nagar Haveli, at a time when Indian pharmaceutical and healthcare product makers are facing increased scrutiny from US regulators over quality standards and manufacturing practices.

According to the FDA inspection report, the regulator identified multiple deficiencies at the plant, raising concerns over potential microbiological contamination and non-compliance with manufacturing standards.

The agency observed lapses in equipment cleaning, maintenance and quality control procedures at the facility. It also alleged that certain manufacturing records had been falsified to hide the use of equipment for products other than those for which it had been designated.

Among the observations mentioned in the report, FDA inspectors found a live bird and bird droppings inside a raw material warehouse located close to packaging materials. Inspectors also reported spotting an unidentified black substance covering large portions of ceiling surfaces in raw material and finished product storage areas.

The FDA further raised concerns regarding the reliability of microbiological testing carried out at the plant. While official records reportedly showed that samples met prescribed safety limits, inspectors observed significant contamination in several samples during the inspection process.

The report also stated that the company’s management failed to adequately review production and quality records before releasing batches into the market, potentially compromising regulatory compliance.

Dabur India, one of the country’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 on the FDA observations.

Companies issued an FDA Form 483 are generally required to submit corrective action plans addressing the deficiencies identified during inspections.

–IANS

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