FDA Flags Manufacturing, Data Integrity Lapses at Dabur India Plant
NEW DELHI — The U.S. Food and Drug Administration has flagged manufacturing, maintenance and data integrity lapses at a Dabur India facility in Dadra and Nagar Haveli, raising concerns about quality controls at the plant.
The inspection findings come as Indian pharmaceutical and health care product makers face increased scrutiny from U.S. regulators over manufacturing practices and compliance with quality standards.
According to the FDA inspection report, regulators identified multiple deficiencies at the facility, including issues that could raise the risk of microbiological contamination. Inspectors cited lapses in equipment cleaning, maintenance and quality control procedures.
The FDA also alleged that some manufacturing records had been falsified to conceal the use of equipment for products other than those for which it had been designated.
Among the observations in the report, inspectors found a live bird and bird droppings inside a raw material warehouse located near packaging materials. Inspectors also reported seeing an unidentified black substance covering large portions of ceiling surfaces in raw material and finished product storage areas.
The agency further raised concerns about the reliability of microbiological testing conducted at the plant. While official records reportedly showed that samples met prescribed safety limits, inspectors observed significant contamination in several samples during the inspection.
The report also said company management failed to adequately review production and quality records before releasing batches into the market, potentially affecting regulatory compliance.
Dabur India, one of India’s oldest consumer goods companies and a major supplier of Ayurvedic and over-the-counter health care products in the U.S. market, did not immediately respond to Reuters’ request for comment on the FDA observations.
Companies that receive an FDA Form 483 are generally required to submit corrective action plans addressing the deficiencies identified during inspections. (Source: IANS)
