New Delhi, May 31: The U.S. Food and Drug Administration (FDA) has raised serious objections regarding manufacturing and data integrity issues at a Dabur India facility located in Dadra and Nagar Haveli.
This objection comes at a time when Indian pharmaceutical and healthcare product manufacturers are facing increased scrutiny from U.S. regulators concerning quality standards and manufacturing practices.
According to the FDA’s inspection report, numerous deficiencies were identified at Dabur’s manufacturing plant, raising concerns about potential microbial contamination and compliance with manufacturing standards.
The regulatory agency found shortcomings in equipment cleaning, maintenance, and quality control processes. Additionally, it alleged that some manufacturing data had been manipulated to conceal the use of equipment for products other than those intended.
The report noted that FDA inspectors discovered a live bird and bird droppings in the raw material warehouse adjacent to packaging materials. They also observed an unidentified black substance on a large portion of the ceiling surfaces in both raw material and finished product storage areas.
The FDA expressed concerns about the reliability of microbiological testing conducted at the plant. Although official data reportedly indicated that samples were within safety limits, inspectors found contamination in several samples during the inspection process.
Furthermore, the report stated that the company’s management did not properly review production and quality records before supplying goods to the market, potentially leading to regulatory compliance lapses.
Dabur India, one of the oldest consumer goods companies in the country and a major supplier of Ayurvedic and over-the-counter health products in the U.S. market, has not issued any statement regarding the FDA’s comments.
Typically, companies that receive Form 483 from the FDA are required to submit a corrective action plan to address the deficiencies found during the inspection.
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ABs
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