FDA Flags Major Sanitation, Record-Keeping Falsification At Dabur India Plant

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India-West News Desk

NEW DELHI – US regulators have cited serious manufacturing and sanitation violations at a production facility in Dadra and Nagar Haveli operated by Dabur India, according to an inspection report released this week, raising new concerns over compliance standards at one of India’s best-known makers of health and personal care products.

The inspection carries particular significance in the United States, where Dabur markets a range of over-the-counter healthcare products, including antifungal treatments, pain relief gels, vapor rubs, and oral care items sold through mainstream retail and online channels.

The findings stem from a January inspection by the U.S. Food and Drug Administration, which documented multiple deficiencies at the plant, including falsification of manufacturing records, quality controls, and conditions that inspectors said could create contamination risks.

According to the FDA report, investigators found evidence that production records had been altered to obscure how certain equipment was being used, with machinery assigned to specific products reportedly used across multiple manufacturing processes. The agency also said company officials did not adequately review production and quality documentation before batches were approved for release.

FDA inspectors also noted sanitation issues inside warehouse areas tied to the facility. The report said a live bird and bird droppings were found in a raw material storage area near packaging supplies. Investigators additionally observed dark unidentified residue covering large portions of ceiling surfaces in both raw material and finished goods warehouses.

The agency also questioned the reliability of microbiological testing performed at the site. Additional observations cited weaknesses in equipment cleaning and maintenance procedures.