Daijiworld Media Network - New Delhi

New Delhi, Jun 1: The United States Food and Drug Administration (FDA) has identified a series of serious manufacturing and quality-control deficiencies at a manufacturing facility operated by Dabur India in Dadra and Nagar Haveli, adding to growing regulatory scrutiny of Indian healthcare and pharmaceutical product manufacturers supplying the US market.

According to an FDA inspection report, regulators observed multiple lapses related to manufacturing practices, equipment maintenance, sanitation standards and data integrity, raising concerns about potential contamination risks and compliance with quality requirements.

Among the issues highlighted during the inspection were shortcomings in equipment cleaning and maintenance procedures, as well as weaknesses in quality assurance systems. The regulator also alleged that certain production records had been altered or falsified to conceal the use of equipment for products beyond its designated purpose.

Inspectors reported finding a live bird and bird droppings inside a warehouse used for storing raw materials, located in close proximity to packaging supplies. The report also noted the presence of an unidentified black substance covering sections of the ceiling in both raw material storage and finished goods areas, prompting concerns over facility hygiene and contamination controls.

The FDA further questioned the reliability of microbiological testing conducted at the site. While company records reportedly indicated that product samples met required safety standards, inspectors observed evidence of significant contamination in several samples during the inspection process.

Another key concern raised by regulators related to the company's batch release procedures. According to the report, management failed to conduct adequate reviews of manufacturing and quality-control records before products were approved for distribution, potentially compromising compliance with established regulatory standards.

The observations come at a time when Indian manufacturers are facing heightened scrutiny from international regulators regarding product quality, documentation practices and manufacturing controls.

Dabur India, one of India's oldest and most prominent consumer healthcare companies, exports a range of Ayurvedic, personal care and over-the-counter healthcare products to international markets, including the United States. The company had not issued an immediate response to media queries regarding the FDA's findings at the time of reporting.

The observations were issued through an FDA Form 483, a document used by the agency to notify companies of conditions that may violate regulatory requirements. Firms receiving a Form 483 are typically expected to investigate the findings and submit detailed corrective and preventive action plans outlining how the identified deficiencies will be addressed.

The outcome of Dabur's response and any subsequent FDA review will determine whether additional regulatory measures or enforcement actions are warranted.