Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre ...
Abbott Laboratories is cited for four key alleged violations related to the production of its Freestyle Libre continuous glucose monitoring devices.
Abbott Laboratories (NYSE:ABT) received an FDA warning letter focused on the accuracy and testing of its FreeStyle Libre ...
The FDA warns Target and Walmart after recalled infant formula remained on sale, causing dozens of babies across the country ...
Cohance Lifesciences Limited has received a Warning Letter from the U.S. Food and Drug Administration (USFDA) for its ...
FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...
In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to manufacturers, as well ...
Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.
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