Abbott Laboratories is cited for four key alleged violations related to the production of its Freestyle Libre continuous ...
The letter, which the FDA has not yet published, does not affect Beta Bionics’ ability to market, manufacture or distribute ...
Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre ...
FDA warning letter data reveals the same top 10 compliance issues have plagued medtech for 20 years, with CAPAs leading at 12 ...
Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.