Federal health officials have identified serious safety and record-keeping violations at a manufacturing facility operated by Dabur India, following an inspection conducted in January at the company’s plant in Dadra and Nagar Haveli.
The Food and Drug Administration’s inspection report, released publicly this week, detailed multiple concerns including potential contamination hazards and deliberate falsification of production records. Dabur India represents one of the country’s most established consumer goods manufacturers, operating for more than 140 years and marketing itself as a leading global distributor of Ayurvedic health products.
The company distributes various over-the-counter health items in the American market, including products for cough and cold relief, antifungal treatments, pain management gels, and dental care items.
According to the inspection findings, certain areas within the manufacturing facility presented microbiological contamination dangers. Federal inspectors discovered that essential production documentation had been deliberately altered to hide the fact that equipment designated for specific products was actually being utilized for manufacturing multiple different items.
The report documented unsanitary conditions including the presence of a live bird and bird waste in the raw materials storage facility, located approximately 30 feet from packaging supplies. Additionally, inspectors observed an unidentified dark substance covering more than one-quarter of ceiling areas in both the raw materials warehouse and the finished product storage facility.
These discoveries occur during a period of increased regulatory oversight of Indian pharmaceutical manufacturers regarding quality control standards for medical products shipped to the United States, which represents their primary international market.
Federal inspectors also raised questions about the facility’s testing procedures, noting that while laboratory results for microbiology tests appeared to meet acceptable standards, substantial contamination was actually observed in numerous samples during the on-site inspection.
The company has not yet provided a response to requests for comment regarding the inspection findings.
After receiving a form 483 notice, which is standard procedure following FDA facility inspections, companies typically submit detailed responses outlining corrective measures they plan to implement to address identified issues.
The inspection report additionally noted that facility management had failed to properly review production and quality documentation to ensure regulatory compliance before releasing product batches for sale, and identified shortcomings in equipment cleaning and maintenance protocols.
