The U.S. Food and Drug Administration (FDA) has given Pfizer’s (pfe) Meridian Medical Technologies unit a warning over multiple violations at the Brentwood, Mo. manufacturing plant where it makes EpiPen products for Mylan (myl).
If Meridian does not correct the violations, the agency said, the result may be “legal action without further notice including, without limitation, seizure and injunction”—and, ultimately, the withholding of contracts from other federal agencies.
Meridian had to issue a recall of the EpiPen and EpiPen Jr. auto-injectors at the end of March as some of the devices, which are used for treating allergic reactions, had a defective part that potentially stopped them from working—an event that could be life-threatening.
This was following an FDA inspection that took place from February to March. In the FDA’s warning letter this week, the agency excoriated Meridian for what it had found, laying out “significant violations” of the Federal Food, Drug and Cosmetic Act.
The FDA ordered Meridian to review its manufacturing investigations and provide analyses of its processes for spotting quality problems and validating component designs.
“You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness,” the warning read. “You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.”
The FDA described how, in February 2016, Meridian had spotted a faulty component in an incoming lot. It rejected the lot and one other, but “did not examine any units from the associated lot to determine whether additional units were affected by the same or similar manufacturing defects.” Meridian then continued to make EpiPens using other lots of the component, while it waited for the results from an investigation it had requested from the supplier.
“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 FDA wrote.
Regarding Meridian’s processes, it added: “Your firm does not assess the types or causes of rejects, and instead only records the total number of rejects. Therefore, your firm does not adequately analyze processes to identify existing and potential causes of nonconformities related to product or other quality problems.”
“It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals,” Pfizer said in an emailed statement. “We currently have no information to show that there was any causal connection between these product complaints and any patient deaths. We are very confident in the safety and efficacy of EpiPen products being produced at the site.”
This article has been updated to include Pfizer’s statement.