Warning Letter — Dabur India Limited
The FDA issued a Warning Letter to Dabur India Limited on July 24, 2024, following an evaluation by the Center for Drug Evaluation and Research (CDER).
This affects Dabur India Limited, their drug manufacturing operations, and associated quality and regulatory departments responsible for U.S. market compliance.
The issuance of a formal Warning Letter by CDER indicates significant deviations from Current Good Manufacturing Practice (CGMP). This regulatory action suggests that the firm's quality systems may be inadequate, potentially leading to supply chain disruptions or administrative holds on pending drug applications originating from the affected facility.
Regulatory and QA departments should review site-specific CGMP adherence and prepare for potential import restrictions if remediation is not prioritized. Immediate focus should be placed on addressing the specific deficiencies cited by CDER to prevent further escalation to an import alert.
FDA Warning Letter issued to: Dabur India Limited. 07/24/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026
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