# FDA 483 - Sanofi Winthrop Industrie - April 17, 2023

Source: https://www.globalkeysolutions.net/records/483/sanofi-winthrop-industrie/76a25104-5f68-460b-8516-b5034d4deebd

> FDA 483 for Sanofi Winthrop Industrie on April 17, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sanofi Winthrop Industrie
- Inspection Date: 2023-04-17
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sanofi Winthrop Industrie in Le Trait, France, revealed significant deficiencies across multiple areas of their manufacturing operations. Key issues included recurrent foreign particulates in sterile products due to inadequate quality control and supplier management, and a lack of sufficient GMP training leading to unqualified operators performing critical tasks. Additionally, the firm failed to implement representative sampling for visual inspection, adequately validate aseptic processes through media fills, and properly monitor environmental conditions in aseptic areas.

## Related Documents

- [483 - 2016-07-19](https://www.globalkeysolutions.net/records/483/sanofi-winthrop-industrie/967e25d3-6bbb-47d9-b7d3-f70cecc0c186)
- [483 - 2018-05-25](https://www.globalkeysolutions.net/records/483/sanofi-winthrop-industrie/6ada0c08-1259-42cf-8578-19c7b77b8e83)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/sanofi-winthrop-industrie/2b248c3f-876e-4da1-94a5-fb2b41a84f5d)

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.globalkeysolutions.net/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Umee Ranjan](https://www.globalkeysolutions.net/people/umee-ranjan/fb531020-cb8b-4c90-b638-abb203a2e556)

Company: https://www.globalkeysolutions.net/companies/sanofi-winthrop-industrie/c811b5aa-08fe-4a09-ae00-f302ada6f489

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