cGMPs / Drug Delivery

FDA Says Pfizer Failed to Investigate EpiPen Failures

Sep 08, 2017

According to an FDA warning letter, Meridian Medical Technologies, a Pfizer company that manufactures EpiPen auto-injectors, failed to properly investigate more than 100 complaints that the device malfunctioned.

The warning letter, which discusses the inspection of Meridian Medical's Missouri manufacturing facility in late February of this year, points to Pfizer’s own data, stating, “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…You did not thoroughly investigate these complaints.”

The FDA also noted that Pfizer’s follow up to complaints did not include removing potentially defective products from the marketplace, even after identifying a defect in one of the critical components used to manufacture these products.

Pfizer claims the company had "no information to indicate that there was any causal connection between these product complaints and any patient deaths."

Read the Warning Letter