FDA Warns EpiPen Makers Over Manufacturing Faults
The U.S. Food and Drug Administration sent a warning letter to Meridian Medical Technologies, a unit of Pfizer, charging that it failed to investigate multiple complaints that some EpiPen auto-injectors, distributed by Mylan N.V., had failed during emergencies, including some that involved fatalities.
September 08, 2017 at 03:49 PM
4 minute read
Makers of the EpiPen failed to investigate multiple complaints that the product malfunctioned during life-threatening emergencies, including some instances in which patients died, the U.S. Food and Drug Administration charged Thursday.
In a warning letter the FDA sent Meridian Medical Technologies Inc. on Tuesday and publicly announced Thursday, the agency told the company that it also failed to adequately respond after the manufacturer identified faults in some of its life-saving allergy auto-injectors. These faults included a failure to activate 171 times between 2014-17, according to user complaints, and the device's failure to deliver the epinephrine in it when needed, the letter said.
The FDA letter advised the company to “correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.” The letter further stated that unresolved violations could prevent other federal agencies from awarding the company contracts.
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