The US Food and Drug Administration (FDA) has issued a warning letter to Meridian Medical Technologies, concerning the manufacture of epinephrine auto injectors.
Warning
Significant violations of current good manufacturing practice (cGMP) for the epinephrine auto injectors — including Mylan’s EpiPen and EpiPen Jr — were identified following an inspection of the company’s manufacturing plant in Missouri. These infringements, summarised in the letter, included drug cGMP violations and QS regulation violations.
The FDA stated that it is now the company’s responsibility to investigate all the violations, determine the causes as well as prevent the recurrence of the violations and that of others at the facility. It has given the company 15 working days to respond to the letter with specific details on its corrective actions relating to the violations.
Additionally, in a statement, the FDA confirmed that it ‘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’. Furthermore, the FDA noted it is ‘not aware of defective EpiPens currently on the market’ but it ‘recommends that consumers use their prescribed epinephrine auto injector’.