# Sanofi Winthrop Industrie – FDA 483, Sep 18, 2017

Source: https://www.keypedia.com/records/483/sanofi-winthrop-industrie/6d998153-5531-4e1b-90d5-4124927dcb02

> FDA 483 for Sanofi Winthrop Industrie on September 18, 2017. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanofi Winthrop Industrie
- Inspection Date: 2017-09-18
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sanofi Pasteur S.A. in Marcy l'Etoile, France, a licensed biological manufacturer, revealed significant deficiencies across multiple critical areas. Issues included an inadequate stability program for rabies vaccine, failures in aseptic processing simulations, and untimely reporting of serious adverse events to VAERS. The firm also exhibited weaknesses in its CAPA system, OOS investigations, visual inspection program, process validation, and personnel gowning practices.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/scott-e-norris/8093919d-6e81-4629-8715-5e78be5c953a)
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Company: https://www.keypedia.com/companies/sanofi-winthrop-industrie/851434de-295b-430d-b638-f2e9f50b0531

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