Date:
May 26, 2026
Content:
The U.S. Food and Drug Administration (FDA) has released a Form 483 report regarding Dabur India Limited following an inspection of its manufacturing facilities in India.
The inspection, which concluded on January 16, 2026, resulted in several observations documented by FDA investigators. A Form 483 is typically issued when an inspection reveals conditions that may violate the Federal Food, Drug, and Cosmetic Act or other regulatory requirements related to manufacturing safety and quality.
Dabur India Limited is expected to address these observations by providing a detailed corrective action plan to the FDA. The goal of this process is to ensure that all manufacturing practices align with current Good Manufacturing Practice (cGMP) standards to maintain product safety and efficacy.
Source: FDA Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/dabur-india-limited-01162026
Keywords:
FDA, Dabur India Limited, Form 483, India, Drug Manufacturing, Inspectional Observations