Earlier this week, Meridian Medical Technologies — a division of Pfizer and a manufacturer of EpiPen— received a warning letter from the FDA accusing it of severe component and product failures that have been linked to serious illnesses and deaths.
The FDA indicated it may recede approval of the company’s future applications until the violations are corrected. The FDA also stated that Meridian Medical Technologies' failure to fix the violations “promptly” could lead to legal action such as injunction and seizure.
“Your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died,” the letter from the FDA states. “You instructed your supplier to undertake a full investigation and corrective actions regarding [EpiPen’s] firing defect, but continued to manufacture finished products using other lots of the same component while the supplier’s investigation remained open until October 2016.”
Meridian Medical Technologies is also accused of failing to sufficiently analyze a number of work processes including work operations, concessions and quality audit reports as well as adequately demonstrate and sustain processes for verifying and validating the EpiPen design.
The FDA stated that Meridian Medical Technologies has 15 working days from receiving the letter to rectify the violations and keep them from occurring again.
A Mylan spokesperson had not responded to Healio Family Medicine’s request for comment prior to publication. Meridian Medical Technologies and Pfizer could not be reached for comment. – by Janel Miller