A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter.
Representatives of the company, Pfizer’s Meridian Medical Technologies, were ordered to meet with FDA regulators to discuss several violations of current good manufacturing processes, the letter said.
The findings were based on FDA inspections of the company’s plant in Brentwood, Missouri, in February and March. The FDA noted it had flagged similar GMP violations in a 2014 inspection, which the company said it would correct.
“These repeated failures demonstrate that your facility’s oversight and control over the manufacture of these products is inadequate,” the letter said.
Epinephrine is intended for emergency treatment of serious allergic reactions, including anaphylaxis.
In February 2016, Meridian Medical identified a faulty injector component among a lot delivered from a supplier — a crucial part that ensures the auto-injector fires properly and delivers the epinephrine, the FDA said.
Meridian rejected that lot and told the supplier to fix the defect, but Meridian continued manufacturing EpiPens using other lots of the component while the supplier’s investigation was ongoing — and didn’t connect the problem to numerous complaints it received about activation failures, the letter said. It recalled the potentially inoperable injectors only after the FDA inspection and repeated meetings with regulators, the FDA said.