FDA 483 - Alexion Pharmaceuticals, Inc. - February 13, 2015

Synageva Biopharma Corp. in Holden, MA, a drug substance manufacturer, was cited for significant deficiencies in its quality unit, analytical testing, material controls, contamination prevention, environmental monitoring, and equipment qualification. The inspection revealed a pattern of inadequate investigations into microbial contamination, scientifically unsound testing procedures, and a lack of robust controls to ensure product quality and purity, particularly concerning its unpurified bulk active pharmaceutical ingredient. These issues indicate a serious lack of adherence to good manufacturing practices.