FDA Alleges Dabur Plant Maintained Misleading Records to Conceal Manufacturing Activities

US FDA Accuses Dabur India of Manufacturing Violations

The US Food and Drug Administration (FDA) has issued a Form 483 inspection report, accusing Dabur India of manufacturing violations at its OTC manufacturing facility in Dadra and Nagar Haveli. The report, released on an unspecified date, alleges that the company created "fraudulent equipment usage documentation" to conceal multi-product manufacturing operations at the facility.

The inspection, conducted between January 12 and January 16, 2026, revealed several serious concerns, including "systematic data integrity issues" and questionable microbiology testing practices. The FDA also flagged missing sample documentation and contamination risks during the inspection. Specifically, the regulator noted that the company allegedly created new equipment usage records between April 2024 and December 2025 that deliberately removed references to several US OTC products manufactured using the same equipment.

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The FDA also raised concerns over the reliability of microbiology testing conducted at the plant. The regulator noted that more than one set of finished product microbiology records reviewed during the inspection showed 100 percent of results being reported as "<10" or zero colonies, despite FDA investigators observing visible microbial colonies during plate reading activities, including plates classified as "too numerous to count" (TNTC).

In another observation, the FDA said duplicate microbial testing data exhibited repetitive numerical patterns that "suggest the data may not reflect actual analytical test results." The inspection report further alleged that multiple microbiology testing plates documented in analytical notebooks were missing during the inspection, with no documentation explaining their disposal or location.

The FDA also flagged deficiencies in cleaning validation protocols for non-dedicated manufacturing lines used across multiple OTC drug products. The regulator said the company relied primarily on visual inspection standards without establishing scientifically justified carryover limits or microbiological cleanliness thresholds.

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The FDA warned that inadequate cleaning validation and the alleged misrepresentation of dedicated manufacturing equipment could create cross-contamination risks affecting batches of OTC pharmaceutical products that remain within expiry periods. Separately, the inspection documented sanitation-related concerns at the facility, including the presence of a live bird and bird droppings in the raw material warehouse located near packaging materials.

The FDA further alleged that the quality control unit failed to adequately investigate the absence of microbiological out-of-specification results over the past five years and failed to establish proper analytical controls. A Form 483 is issued at the conclusion of an FDA inspection when investigators observe conditions that may violate US drug manufacturing regulations. It does not constitute a final regulatory determination or enforcement action, though companies are typically required to submit corrective and preventive action plans in response.