June 11 (Reuters) - The U.S. Food and Drug Administration has issued an import alert for drugs manufactured at Dabur India's ...
Dabur India Ltd reported a US FDA import alert on drugs from part of its Silvassa plant due to data integrity and maintenance ...
By Rishika Sadam May 29 (Reuters) - The U.S. Food and Drug Administration has flagged data integrity, manufacturing and ...
BETHESDA, MD – Data integrity issues were the primary reason for the US Food and Drug Administration’s (FDA) delay in approving abbreviated new drug applications (ANDAs) past their review goal date, ...
The US FDA has issued Import Alert 66-40 for drugs manufactured at a part of Dabur India’s Silvassa facility after ...
Inspectors at the US Food and Drug Administration (FDA) say lack of data integrity, transparency, record retention, and inadequate controls are some of the most common issues they see during ...
The US FDA has placed drugs made at Dabur India's Dadra and Nagar Haveli factory under import alert after an inspection.
The FDA recently announced that it had identified “significant data integrity and study conduct concerns” in various bioequivalence studies conducted by the India-based contract research organization, ...
The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have failed to comply with good manufacturing norms ...
The US FDA has issued a Form 483 to Dabur India following an inspection of its Dadra and Nagar Haveli plant. Discover the ...
The U.S. Food and Drug Administration (FDA) announced a “real-time clinical trials” (RTCT) pilot program to permit agency reviewers to review ...
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