# Sanofi Vaccines US Inc. – FDA 483, Nov 6, 2025

Source: https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/7339d770-c7b4-4c97-94b3-f19edfcec568

> FDA 483 for Sanofi Vaccines US Inc. on November 06, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Vaccines US Inc.
- Inspection Date: 2025-11-06
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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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- [EIR - 2018-10-26](https://www.keypedia.com/records/eir/sanofi-vaccines-us-inc/db1cb36f-bcff-41df-ae66-4e0afc24e462) — date: October 26, 2018

## Related Officers

- [Prajakta A. Varadkar](https://www.keypedia.com/people/prajakta-a-varadkar/93c01972-2e91-462e-8c2b-4a6520d3dd3f)
- [company_representative](https://www.keypedia.com/people/wang-xia/00d972f9-dd57-4665-a95e-b16123ef85a3)

Company: https://www.keypedia.com/companies/sanofi-vaccines-us-inc/94f5ecde-ae72-47f6-b6b7-ca9126ef544f

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4