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
