- Alexion has been cited by the FDA for lax manufacturing practices at its Rhode Island-based Soliris (eculizumab) plant.
- The FDA identified at least three production issues during a recent inspection.
- These newly-identified problems are unrelated to the issues that forced the FDA to send Alexion a warning letter in 2013.
FDA inspectors have identified a need for better training related to gowning procedures, as well as a need for more frequent environmental monitoring and processes related to identifying the underlying cause of the previous sterility failure.
Two months ago, Alexion recalled nine lots of its blockbuster Soliris, which is used to treat a rare blood disorder that can lead to kidney failure. Considering that Soliris is a $450,000-per-year drug, being forced to halt production due to manufacturing violations could prove quite costly. However, Alexion is continuing to make Soliris while addressing its manufacturing-related challenges in order to ensure patient supply .