Alexion Pharmaceuticals gets Form 483 again by the FDA

The FDA had issued a warning letter last year to Alexion Pharmaceuticals as it did not comply with the current Good Manufacturing Practices at the facility making Soliris used for treatment for combating a rare blood disorder. A re-inspection of the facility by the FDA failed to satisfy the U.S. regulatory agency once again.

Soliris is available for the treatment of two rare genetic disorders: paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. The FDA issued a Form 483 to the company in which three production issues were mentioned following a follow-up inspection of the plant last week. These were different from the issues raised in March 2013 warning letter.

The FDA inspectors cited a need for enhanced training around gowning procedures, more frequent environmental monitoring and processes related to identifying the definitive root cause of a prior sterility failure. The company also recalled 9 lots of Soliris because of possible particulate contamination.