New Delhi: The US Food and Drug Administration (FDA) has identified serious manufacturing, maintenance, and data integrity violations at a Dabur India production facility located in Dadra and Nagar Haveli, amid rising regulatory scrutiny of Indian pharmaceutical and healthcare manufacturers in the United States over quality and compliance standards.
According to the FDA inspection report, multiple deficiencies were observed at the plant, raising concerns about possible microbiological contamination and breaches of established manufacturing norms.
Inspectors noted lapses in equipment cleaning, upkeep, and quality control systems. The report also alleged that certain production records may have been falsified in order to conceal the use of machinery for products other than those it was officially assigned to manufacture.
Among the specific findings, officials reported the presence of a live bird and bird droppings inside a raw material storage warehouse situated near packaging materials. They also observed an unidentified black substance covering extensive areas of ceiling surfaces within both raw material and finished goods storage zones.
The FDA further questioned the reliability of microbiological testing conducted at the facility. While company records indicated that samples were within acceptable safety limits, inspectors reportedly found significant contamination in several samples during on-site examination.
In addition, the report stated that the management did not adequately review production and quality assurance records before releasing batches into the market, raising further concerns about regulatory compliance and product safety.
Dabur India, one of India’s oldest consumer goods companies and a major exporter of Ayurvedic and over-the-counter healthcare products to the United States, has not yet responded to Reuters’ request for comment on the FDA findings.
Companies issued a Form FDA 483 are typically required to submit corrective action plans addressing all deficiencies identified during inspections.
With IANS inputs