The U.S. Food and Drug Administration (FDA) has identified significant data integrity, manufacturing, and maintenance deficiencies at a manufacturing facility operated by Dabur India following an inspection conducted in January at the company’s plant in Dadra and Nagar Haveli.
According to the inspection report, the regulator raised concerns over potential microbiological contamination risks, inadequate quality control procedures, and the reliability of manufacturing records at the facility, which produces healthcare and consumer products for international markets, including the United States.
The FDA reported that certain manufacturing areas and storage facilities exhibited conditions that could compromise product quality. Inspectors observed a live bird and bird droppings inside a raw material warehouse located near packaging materials. They also noted the presence of an unidentified black substance covering significant portions of ceiling surfaces in both raw material and finished product storage areas.
The inspection further revealed alleged data integrity issues, with critical manufacturing records reportedly altered to conceal the use of production equipment for multiple products. The regulator stated that such practices could undermine the accuracy and reliability of production documentation.
In addition, FDA inspectors questioned the credibility of microbiological testing conducted at the facility. While company records indicated that samples met prescribed limits, inspectors reportedly observed substantial contamination in several samples during the inspection process.
The report also highlighted shortcomings in equipment cleaning and maintenance practices. According to the regulator, management failed to adequately review production and quality records before authorizing the release of product batches to the market, a key requirement under current good manufacturing practices.
The findings come amid heightened scrutiny of Indian manufacturers exporting medicines and healthcare products to the United States, one of the industry’s largest overseas markets. Regulatory agencies have increasingly focused on data integrity, quality assurance systems, and manufacturing compliance across global supply chains.
Dabur India, one of India’s oldest consumer goods companies and a major producer of Ayurvedic and healthcare products, markets a range of over-the-counter products internationally, including pain relief gels, oral care products, cough remedies, and antifungal treatments.
The company had not issued an immediate response to the inspection findings. Typically, manufacturers receiving an FDA Form 483 are required to submit corrective and preventive action plans outlining steps taken to address the regulator’s observations.
The inspection report was made public earlier this week and is expected to prompt remedial measures at the facility as the company works to address the identified compliance gaps.