FDA 483 - Dabur India Limited - January 16, 2026

From January 12 to 16, 2026, the FDA inspected the Dabur India Limited manufacturing facility in Dadra and Nagar Haveli, India. The inspection of this over-the-counter (OTC) drug manufacturer revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, primarily involving data integrity and quality oversight. Investigators discovered that laboratory personnel reported zero microbial growth on 100% of samples despite visible colonies being present during the inspection. Furthermore, the firm falsified equipment logs to conceal that manufacturing lines were used for multiple products, and failed to conduct scientifically sound cleaning validations to prevent cross-contamination. Additional deficiencies included missing analytical data for released batches, the absence of annual product quality reviews, and poor facility maintenance, including bird infestations and stagnant water in manufacturing hoses. While these observations do not constitute a final agency determination, Dabur India Limited is expected to provide a formal response to the FDA. This response must include a comprehensive plan for corrective and preventive actions to address the systematic failures in their quality system and documentation practices.