FDA warns Pfizer company about cGMP violations associated with the manufacture of EpiPen

Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products.

The warning letter identifies significant violations of current good manufacturing practice (cGMP) requirements for its epinephrine auto injectors, including EpiPen and EpiPen Jr, and instructs the company to undertake steps to correct those violations. FDA understands the importance of epinephrine auto-injectors and will work to ensure that the company’s corrections are adequate so that patients can be assured of the safety and efficacy of the products.

In its warning letter, the FDA explained that MMT "failed to thoroughly investigate multiple serious component and product failures" of its EpiPen products, including "failures associated with patient deaths and severe illness".

FDA is not aware of defective EpiPens currently on the market and recommends that consumers use their prescribed epinephrine auto injector.

Pfizer is continuing to work with the FDA to resolve the points raised in the warning letter regarding Pfizer’s manufacturing of the EpiPen products and Mylan says it will do whatever it can to support this process. The warning letter does not affect Pfizer’s ability to manufacture and supply the EpiPen products from the Brentwood, Missouri site, and the company does not currently anticipate any impact on the supply of EpiPen products based on this warning letter. Mylan says it is confident in the safety and efficacy of the EpiPen products being produced at the site.