Dear Ms. Makela: Please refer to your New Drug Application (NDA) dated and received November 16, 2017, and FDA issued a Warning Letter to Meridian Medical Technologies, Inc. a Pfizer Company on 9/5/2017 as a result of this inspection. Dive Brief: The Food and Drug Administration has issued a warning letter to a manufacturer of Mylan N.V.'s EpiPen, underscoring safety concerns related to the life-saving drug's production that began earlier this year. FDA Inspection Records - Meridian Medical Technologies, A Pfizer Company, Brentwood, MO, FEI 1950222 Item Preview 1 FDA483 MMT Brentwood MO Insp 2 20 2017-3 24 2017.pdf The FDA sent the warning letter to Meridian for multiple violations. FDA alerts health care providers and emergency responders of expiration date extensions of certain auto-injectors manufactured by Meridian Medical Technologies; May 13, 2014 FDA further extends expiration dates of DuoDote auto-injector lots manufactured by Meridian Medical Technologies; March 28, 2014 Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products. Attention: Cristina Makela, MS . In its warning letter, the FDA noted that Meridian staff had said the company initiated a recall of some EpiPens only after government prodding. 2017. The latest news, announcements and press releases from Meridian Medical Technologies, Inc. 29. Meridian Medical Technologies, Inc. In September 2017, the FDA accused of Meridian Medical Technologies of failing to properly investigate hundreds of claims about malfunctions and failures. Director, Regulatory Cluster Lead . September. The FDA sent the manufacturer a warning letter on Sept. 5, 2017, citing “significant violations” of federal regulations. 6350 Stevens Forest Road, Suite 301 . A new Food and Drug Administration (FDA) warning letter to Meridian Medical Technologies, a US EpiPen manufacturer, suggests some EpiPens on the market were defective. The manufacturer, Meridian Medical Technologies, didn't properly look into those complaints, FDA inspectors warned as far back as 2014. epinephrine Meridian Medical Technologies EpiPen Warning letter current good manufacturing process (cGMP) Food and Drug Administration (FDA) auto … Columbia, MD 21046-3242 . FDA Warning: EpiPen Maker Failed to Investigate Problems. FDA has issued a warning letter to Pfizer's Meridian Medical Technologies unit that manufactures the emergency auto-injector EpiPen, saying the company "failed to thoroughly investigate" product failures even in cases of patients' deaths.

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