# FDA 483 - Sanofi Pasteur - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/sanofi-pasteur/b567c76c-c88b-4490-bedc-15a40ee5c9c5

> FDA 483 for Sanofi Pasteur on September 29, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sanofi Pasteur
- Inspection Date: 2023-09-29
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sanofi Pasteur's vaccine manufacturing facility in Marcy-L'Etoile, France, revealed significant deficiencies in manufacturing and quality control. Observations included incomplete master production records for vaccine components, inadequate investigations into product discrepancies, and improper storage conditions for drug products. Additionally, the firm exhibited insufficient laboratory controls and a failure to follow aseptic practices during sterile manufacturing, raising concerns about product quality and sterility.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.globalkeysolutions.net/records/warning_letter/sanofi-pasteur/83df4bd6-3bef-4f07-88ad-284d3832d2d7)
- [483 - 2017-09-27](https://www.globalkeysolutions.net/records/483/sanofi-pasteur/2530fb86-0a63-4084-8006-ec611489a35e)
- [483 - 2017-09-18](https://www.globalkeysolutions.net/records/483/sanofi-pasteur/6d998153-5531-4e1b-90d5-4124927dcb02)

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/sanofi-pasteur/851434de-295b-430d-b638-f2e9f50b0531

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