FDA issues warning letter to defibrillator battery manufacturer

The FDA issued a warning to Amco International Manufacturing & Design for continuing to produce and distribute batteries for automated external defibrillators (AEDs) without the required premarket approval (PMA). This requirement was established in 2015, with a final deadline in February 2022. Despite multiple extensions, including those due to COVID-19, Amco failed to comply.

An FDA inspection in March revealed that Amco was still making batteries for AEDs used by companies like Philips, Stryker, and Zoll, classifying these products as adulterated under U.S. law. The FDA has ordered Amco to stop these activities and take corrective actions, giving the company 15 business days to respond. Previously, Amco's website listed these AED batteries, but this section has since been removed. Amco also works in other fields, such as communication and thermal imaging.