EpiPens US Food and Drug Administration inspectors raised concerns
The EpiPen is a treatment for severe allergic reactions. People who carry EpiPens rely on them to work in emergency, life-or-death situations.
US Food and Drug Administration inspectors raised concerns about how the product was being manu、factured over the last few years, including in 2017 around the time of a large EpiPen voluntary recall.
FDA inspectors had also been telling the EpiPen’s manufacturer, a unit of drug giant Pfizer called Meridian Medical Technologies, for years that it should be taking complaints fr、om customers about malfunctioning EpiPens more seriously, Business Insider recently reported for the first time.
Meridian has said that it is challenging to test EpiPens before they get into patients’ hands because the one-time devices are destroyed in the process.
Pfizer told Business Insider that it is “very confident” in its EpiPens and that the manufacturing process has many steps of “stringent controls.”
Business Insider
Meridian Medical Technologies, Inc. a Pfizer Company 9/5/17
September 5, 2017
WARNING LETTER
Ref: CMS Case: 525881
Mr. Thomas E. Handel
President and General Manager
Meridian Medical Technologies, Inc., a Pfizer Company
6350 Stevens Forest Road, Suite 301
Columbia, MD 21046
Dear Mr. Handel:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Meridian Medical Technologies, Inc. (MMT) at 2555 Hermelin Drive, Brentwood, Missouri, from February 20 to March 24, 2017.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm574981.htm