Hundreds of EpiPen users complained about problems with the lifesaving device. It still took 3 years and a top regulator stepping in before serious change — with potentially deadly outcomes

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People with life-threatening allergies rely on the EpiPen in emergencies. Complaints about EpiPens not working or arriving in bad shape began to mount in 2013 and 2014. The manufacturer, Meridian Medical Technologies , didn’t properly look into those complaints, FDA inspectors warned as far back as 2014. Meridian didn’t make significant changes to its complaint-investigation process until three years later, after a major voluntary recall of EpiPens.

https://www.businessinsider.com.au/fda-warned-epipen-complaints-pfizers-meridian-factories-2019-1

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