FDA 483 - Sanofi Pasteur Inc.

An FDA inspection of Sanofi Pasteur Inc. in Swiftwater, PA, a vaccine manufacturer, revealed significant deficiencies across its manufacturing and quality control operations. The firm was cited for inadequate aseptic processing controls, including cross-contamination risks and validation issues, as well as widespread data integrity and record-keeping problems. These findings indicate a systemic lack of control over critical processes and data, posing potential risks to product quality and sterility.