Business
05 Aug, 2026
USFDA issues warning letter to Dabur over alleged violation of current good manufacturing practices
Business To Business, New Delhi, 05 August, 2026: The U.S. Food and Drug Administration (USFDA) has issued a warning letter to Dabur India, citing significant violations of current Good Manufacturing Practices (CGMP) at the company's pharmaceutical manufacturing facility in Silvassa.
The warning letter follows a USFDA inspection of the Silvassa facility conducted from January to December 16, 2026.
In its letter dated July 24, 2027, addressed to Mohit Malhotra, the USFDA highlighted several concerns, including:
- Data integrity lapses
- Inadequate quality oversight
- Deficient manufacturing controls
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USFDA warning letter is a formal regulatory action indicating that an inspection found significant deviations from required manufacturing standards. Companies receiving such letters are expected to investigate the deficiencies, implement corrective and preventive actions, and demonstrate compliance to the regulator. Failure to adequately address the observations can lead to further regulatory measures affecting the facility's ability to supply products to the U.S. market.