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    FDA Sends Warning Letter to EpiPen Manufacturer

    EpiPen manufacturer is accused of lax investigation into problems.


    According to the letter, Meridian’s reasoning is “inadequate” for why it failed to identify the scope and frequency of the component defect and for why they took little action.

    Complaint procedures at Meridian were also deemed “inadequate.” Any complaints were ranked on a scale from expedite, high, and normal. This scale, according to the FDA is deficient because it doesn’t prioritize complaints based on risk to patients. For example, complaints relating to “failure to active” were marked as expedite. However, complaints relating to spontaneous activation were marked as normal, the lowest priority, even though both complaints would result in the patient not receiving the drug when they used the device.

    Related article: Are EpiPens Still Good After Their Expiration Date?

    The FDA is requiring Meridian to provide a detailed review of all of its manufacturing investigations and future plans for addressing patient safety and product quality concerns. If it does not adequately answer the FDA’s requests for information, it could face shutdown and other legal troubles.

    In a statement, Mylan said that "Pfizer is continuing to work with FDA to resolve the points raised in the letter regarding Pfizer’s manufacturing of EpiPen Auto-Injector and Mylan will do whatever it can to support this process. We note that Pfizer’s recall several months ago of certain lots of EpiPen Auto-Injector was taken as a proactive and precautionary measure with FDA in relation to these issues. Mylan has an unwavering commitment to quality and patient safety and we are confident in the safety and efficacy of EpiPen products being produced at the site. Further, we do not currently anticipate any supply issues as a result of the warning letter.”


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