The US Food and Drug Administration (FDA) on Tuesday warned Pfizer subsidiary Meridian Medical Technologies for failing to adequately investigate faulty components used to make EpiPen and EpiPen Jr auto-injectors for Mylan.
The warning letter comes less than six months after Meridian recalled 13 lots of EpiPens over concerns that a defective part could prevent the injectors from activating properly, and after a month-long inspection of Meridian's Brentwood, MO facility by FDA in February and March.
According to FDA, Meridian "failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness," and did not move to recall products until after FDA began its inspection.
"While [Meridian] eventually expanded the scope of the investigation into affected product lots and recalled all 13 lots distributed to the United States containing potentially deformed [Redacted], [Meridian] did so only after our inspection closed and after multiple discussions with FDA," the agency writes.
The letter comes as Mylan has been criticized for raising the price of its EpiPen by more than 400% and more recently settled with the Department of Justice over allegations of misclassifying EpiPens in the Medicaid Drug Rebate Program.
In February 2016, Meridian rejected two lots of components used in the auto-injectors after discovering a unit that failed to fire when tested.
But FDA says the company failed to inspect other units from those lots to determine if more units were affected, and continued to manufacture auto-injectors with components from other lots made by the same supplier while the supplier's investigation into the defect was underway.
FDA says Meridian failed to link the component failure with "hundreds of complaints" of its auto-injectors failing to activate during life-threatening emergencies.
In one case, FDA says Meridian disassembled an auto-injector that was the subject of a complaint and determined it had the same type of manufacturing defect. According to FDA, Meridian closed out its investigation into the complaint and "concluded that the defect was infrequent, even though [Meridian] had not examined all of [its] reserve samples to determine the extent of the defect within the same lot of finished products."
Meridian also did not disassemble and inspect all of the 171 products it was sent related to customer complaints, though the number it did inspect is redacted from the warning letter.
FDA further cited Meridian for its complaint handling practices, saying that the company's classification system for complaints is inadequate as it does not prioritize complaints based on patient risk.
While Meridian marked complaints for products that failed to activate as high priority, complaints for products that activated spontaneously were classified as "normal," the company's lowest priority rating.
"Both problems result in the patient not receiving the needed drug in a life-threatening situation," FDA writes.