FDA WARNING_LETTER - Dabur India Limited - January 16, 2026

On July 24, 2026, the FDA issued a warning letter to Dabur India Limited following an inspection of its manufacturing facility in Silvassa, India, conducted from January 12 to 16, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, as outlined in 21 CFR Parts 210 and 211, rendering the firm’s over-the-counter (OTC) drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

The primary violations involve severe data integrity failures, including the discovery of falsified equipment logbooks and discrepancies between raw analytical data and reported batch records. Additionally, the firm failed to maintain complete laboratory records, evidenced by missing microbiological test plates and a lack of supporting data for numerous batch releases. The FDA also noted inadequate cleaning validation for shared equipment, which creates a high risk of cross-contamination, and a failure to perform necessary process validation for the majority of their manufactured drugs.

Due to these systemic quality failures, the FDA placed the firm on an Import Alert in June 2026. Dabur India is now required to engage an independent third-party consultant to conduct a comprehensive audit and a retrospective data integrity investigation. The company must provide a detailed corrective and preventive action (CAPA) plan, a management strategy for global remediation, and a timeline for complete process and cleaning validation. A formal response addressing these deficiencies is required within 15 working days.