FDA warns Pfizer subsidiary over Epipen malfunctions

The US Food and Drug Administration (FDA) has formally warned Meridian Medical Technologies after the company failed to properly investigate reports of Epipen adrenaline injector malfunctions. Meridian has three weeks to notify the FDA of how it is addressing problems revealed in an inspection earlier this year.

The agency accuses Meridian, a Pfizer subsidiary, of ‘significant violations’ of good manufacturing practice requirements. For example, in February 2016, Meridian identified a fault in a batch of a crucial auto-injector component. Despite this, the company continued to manufacture Epipens using the component over the next eight months, while its supplier was investigating the issue.