FDA 483 - Dabur India Limited - January 16, 2026

During an inspection from January 12 to January 16, 2026, the FDA identified significant systemic failures at the Dabur India Limited manufacturing facility located in Dadra and Nagar Haveli, India. The inspection of this over-the-counter (OTC) drug manufacturer revealed severe deficiencies regarding data integrity and quality oversight. Most notably, the Quality Control unit failed to investigate falsified laboratory data, where microbial test results were reported as having zero colonies despite the physical presence of contamination. The firm also documented fraudulent equipment logs to conceal the manufacturing of multiple products on shared production lines, bypassing necessary cross-contamination risks.

Additional violations included scientifically inadequate cleaning validation procedures that relied solely on visual inspections rather than quantitative safety limits. Facility maintenance was also found to be substandard, with evidence of bird infestations and unidentified black substances on warehouse ceilings. Furthermore, the company failed to provide required documentation for batch releases, missed annual product quality reviews, and lacked proper process validation for various medications.

These findings suggest a failure to comply with the regulatory framework of Current Good Manufacturing Practice (CGMP). While the FDA 483 serves as an initial report of observations and not a final determination, Dabur India Limited is required to respond with a detailed corrective action plan. This response must address the identified data integrity issues, establish robust quality controls, and ensure the facility meets sanitary and validation standards to prevent potential product contamination and ensure consumer safety.