# Sanofi Vaccines US Inc. – FDA 483

Source: https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/ecac1e06-2dca-4ed9-bfc8-8d7c8ebd3481

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sanofi Pasteur, Inc. in Swiftwater, PA, a vaccine manufacturer, revealed two significant observations. The firm failed to follow procedures for YF-VAX production operations, specifically regarding conveyor speed adjustments during lyophilizer unloading. Additionally, the firm did not adequately document or evaluate cycle failures associated with a specific line, with no investigation initiated to assess trends or impact on process validation.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/dino-feigelstock/462413b8-21a9-409f-bda0-349b2ac8e08b)
- [investigator](https://www.keypedia.com/people/solomon-yimam/043f0fe2-e686-4b94-b1fa-8be44359db29)
- [investigator](https://www.keypedia.com/people/christian-d-lynch/3b2748d3-3800-4538-939d-71a33dca0b2d)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd