FDA 483 - Sanofi Pasteur Inc. - November 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Sanofi Pasteur Inc. in Swiftwater, PA, a drug substance manufacturer, was cited for significant deficiencies during an FDA inspection. The inspection revealed inadequate routine environmental monitoring, leading to repeated out-of-specification events for Flublok® Quadrivalent and Flublok® Trivalent drug substances. Additionally, the facility was found to be in a state of disrepair and uncleanliness, with issues such as paint chipping, residue, and cracks observed in manufacturing areas.
ID · 7339d770-c7b4-4c97-94b3-f19edfcec568