Alexion Pharmaceuticals, Inc. – FDA 483, Jul 17, 2017

An FDA inspection of Alexion Pharmaceuticals, Inc. in Smithfield, RI, a biological drug substance manufacturer, identified significant deficiencies in equipment and facility maintenance. Observations included inadequate maintenance of tanks and bioreactors with noted rouging and discoloration, and a failure to remediate these issues within required timeframes. Additionally, the firm failed to prevent repeated pest contamination in aseptic controlled manufacturing areas, indicating a lack of environmental control.