FDA 483 - Sanofi Pasteur Inc.

An FDA inspection of Sanofi Pasteur, Inc. in Swiftwater, PA, a vaccine manufacturer, revealed two significant observations. The firm failed to follow procedures for YF-VAX production operations, specifically regarding conveyor speed adjustments during lyophilizer unloading. Additionally, the firm did not adequately document or evaluate cycle failures associated with a specific line, with no investigation initiated to assess trends or impact on process validation.