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EpiPen Maker Faces Manufacturing Violations

What started as a controversy over the price of the pens has only gotten worse.

Mylan – the maker of the life-saving epinephrine shot EpiPen – is having a tough go of it.

What started as a controversy over the price of the pens – a massive hike of 500 percent which made them unaffordable for many – has only gotten worse in terms of public opinion.

In August, Mylan settled with the U.S. government to the tune of $465 million, stemming from allegations that the company overcharged Medicaid an estimated $1.3 billion for its products.

Well, the fun’s not over.

Now the FDA has fired off a warning letter to Meridian Medical Technologies, a division of Pfizer that manufactures the EpiPen for Mylan. The letter says Meridian has failed to investigate numerous complaints that EpiPens were failing during emergencies, some incidents of which resulted in death.

Meridian’s facility was inspected several times earlier this year, and the letter refers to “significant” violations related to manufacturing operations.

Furthermore, the FDA said the company failed to investigate multiple failures of the pens. It charges that Meridian didn’t even disassemble the bulk of the 171 EpiPens that were submitted as having failed to activate in an emergency.

According to Reuters, “both Mylan and Pfizer said they are confident in the safety and efficacy of EpiPen products being produced at the site” and that Mylan doesn’t anticipate supply disruptions.

That said, the wording of the FDA letter – which accuses Meridian of failing to remove “potentially defective products from the marketplace” – certainly can’t help the brand image of EpiPen after its troubled run.

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