Warning Letter Roundup & Recap β 4 March 2020
Three device makers were issued warning letters after US FDA investigators discovered quality systems and Medical Device Reporting violations during facility inspections. A total of four enforcement missives were released by the agency this week.
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As American auto giants GM and Ford take the wheel on working with ventilator manufacturers to make the critically needed devices during the COVID-19 pandemic, two longtime quality experts explain where the device and auto companies will find common ground when it comes to quality systems.
President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.
Medtech manufacturers around the globe should brace for another shock to supply chains now that the COVID-19 pandemic has shifted away from Asia, and toward North America and Europe.