483
Sanofi Vaccines US Inc.Sanofi Vaccines US Inc. – FDA 483, Nov 6, 2025
Record Details
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.
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ID · 7339d770-c7b4-4c97-94b3-f19edfcec568
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