Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during ...
The US FDA has issued a Form 483 to Dabur India following an inspection of its Dadra and Nagar Haveli plant. Discover the ...
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 U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional ...
A Form 483 is issued at the conclusion of an FDA inspection when investigators observe conditions that may violate US drug manufacturing regulations.
The US Food and Drug Administration (FDA) will continue to focus on data integrity practices and take a hard look at OTC firms’ testing programs either through onsite inspections or using alternative ...
Foreign facilities failed FDA GMP inspections at up to 1.8x the U.S. rate. Journal of Pharmaceutical Innovation study quantifies a decade of oversight gaps. We first need rigorous, replicable ways to ...
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the ...
US FDA has flagged multiple deficiencies at Dabur India's manufacturing facility in Dadra and Nagar Haveli, including data integrity, contamination and maintenance concerns. Meanwhile, the Indian ...
The U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January ...
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