Pfizer’s Meridian unit, responsible for the manufacture of EpiPen and Mylan’s EpiPen Generic, is the subject of a civil investigation by the US Attorney’s office for the District of NY.
The company disclosed in a regulatory filing Thursday that it would be responding to a request for documents related to an investigation of quality issues at the facility.
These manufacturing issues resulted in the recall of tens of thousands of EpiPens and EpiPen Generics marketed by Mylan and led to an unprecedented shortage of epinephrine auto-injectors that is still ongoing according to the Food and Drug Administration (FDA).
The company received a letter from the FDA in 2017 warning the company that it had failed to thoroughly investigate product failures that were associated with patient deaths and failed to take corrective actions.
