US FDA flags data integrity, maintenance lapses at Dabur India plant

The US Food and Drug Administration has flagged data integrity, manufacturing and maintenance lapses at one of Dabur India's plants following ​an inspection earlier this year, according to an inspection report.

Dabur ​is one of India's oldest and largest consumer goods companies, describing itself ‌as one of the world's largest suppliers of Ayurvedic products with a legacy of over 140 years. It sells a range of over-the-counter and consumer health products in the United States, including cough and cold rubs, antifungal creams, pain relief gels and oral care products.

The findings, issued after the FDA inspected the company's factory in the country's western region of Dadra and Nagar Haveli in January, said some units in the facility posed risks of microbiological contamination.

 

The report also said critical manufacturing records were falsified to conceal that equipment meant to make certain ‌products had been used for multiple other products.

A live bird and bird droppings were found in the raw material warehouse, about 30 feet from packaging materials. An apparent unidentified black substance was also seen covering more than 25% of ceiling surfaces in both the raw material warehouse and the finished drug product storage warehouse, according to the report, which was made public earlier this week.

The findings come amid heightened regulatory ​scrutiny of Indian drugmakers over quality controls for medicines and health products exported to the United ‌States, their largest overseas market.

The FDA inspector also questioned the reliability of testing at the plant, noting that although microbiology test results were reported as within ​limits, significant ‌contamination was observed in multiple samples during the inspection.

Dabur did not immediately respond to a ‌Reuters request for comment.

Following a form 483, which is issued after a US FDA inspection, companies usually respond to the regulator with corrective steps taken to address ‌the ​concerns.

The report also ​said management had not reviewed drug production and quality records to determine compliance with regulatory requirements before batches were released to the market, and cited ‌deficiencies in equipment ​cleaning and maintenance procedures.