# Sanofi Vaccines US Inc. – FDA 483, Aug 2, 2024

Source: https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/b5e64928-743d-4de3-9574-a18f50711e8d

> FDA 483 for Sanofi Vaccines US Inc. on August 02, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sanofi Vaccines US Inc.
- Inspection Date: 2024-08-02
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: Sanofi Pasteur Inc., a vaccine manufacturer in Swiftwater, PA, was inspected by the FDA. The inspection revealed that input and output from systems controlling manufacturing formulas and data are not checked for accuracy. Specifically, critical adjustments to capping/crimping equipment and selected fill recipe parameters for Fluzone® Influenza Virus Vaccine were not documented, failing to ensure adherence to validated ranges.

## Related Documents

- [483 - 2025-11-06](https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/7339d770-c7b4-4c97-94b3-f19edfcec568) — date: November 6, 2025
- [483 - 2024-01-26](https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/49eddef0-a693-47ad-966c-ecda5ffefdd7) — date: January 26, 2024
- [483 - 2023-04-22](https://www.keypedia.com/records/483/sanofi-vaccines-us-inc/e60a0f17-6ec3-4dd0-8048-0d2095627241) — date: April 22, 2023
- [EIR - 2023-04-22](https://www.keypedia.com/records/eir/sanofi-vaccines-us-inc/6bcbc538-aa67-495c-a379-27e1e0ecd60c) — date: April 22, 2023
- [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

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

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