# Sanofi Vaccines US Inc. – FDA 483

Source: https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/ed387388-5269-411c-a1a1-c05b95cb2b17

> FDA 483 for Sanofi Vaccines US Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Vaccines US Inc.
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: 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.

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## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

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

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8