FDA Issues Warning Letter to EpiPen Manufacturer

On September 5, 2017, FDA issued a warning letter to a Meridian Medical Technologies facility, located in Brentwood, MO, which manufactures Mylan’s EpiPen (epinephrine injection). The warning letter identifies significant violations of current good manufacturing practice (cGMP) requirements for its epinephrine auto injectors, including EpiPen and EpiPen Jr.

During an inspection from February 20 to March 24, 2017, FDA inspectors found that the firm had failed to thoroughly investigate failures of auto-injector components, including a failed sample from an incoming lot, as well as from customer complaints about EpiPens that failed to activate or that spontaneously dispensed prior to use.  

Meridian recalled all 13 lots of EpiPen products that contained a potentially deformed component to the US market on March 31, 2017, according to an FDA announcement. FDA noted, however, that the full recall occurred only after the inspection closed and after multiple discussions with FDA. In the warning letter, FDA stated: “Your response is inadequate. You did not explain why your own investigations failed to identify the scope and frequency of the (b)(4) component defect, or why you had previously concluded that this component defect occurred too infrequently to warrant a market action. You also failed to review all of your investigations to determine whether you had assessed all lots of components and finished products potentially affected by this manufacturing defect. Finally, you did not determine a root cause for any failure-to-activate complaint samples that you determined had functioning (b)(4) and were thus not attributable to the same (b)(4) defect.” FDA called for the company to conduct a comprehensive review.

FDA also cited the firm for inadequate complaint handling procedures, Quality System regulation violations regarding statistical methodology employed to detect recurring quality problems, and inadequate validation of the device design. FDA said the firm’s responses were inadequate and asked for further clarification.

FDA noted that Meridian Medical Technologies has a quality agreement with its customer, Mylan Specialty, but that Meridian Medical Technologies is responsible for the quality of combination products it produces.

“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,” said FDA in a statement.

FDA is not aware of defective EpiPens currently on the market, and recommends that consumers use their prescribed epinephrine auto injector. As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens.

FDA asks health care professionals and consumers to report any adverse reactions or quality problems to the FDA’s MedWatch program.

Source: FDA