Company
FranceSanofi Winthrop Industrie, Marcy-L'Etoile, France – FDA Inspections
Inspection records and compliance data for Sanofi Winthrop Industrie in Marcy-L'Etoile. 7 FDA inspections on record, 4 Form 483s, 1 warning letter, last inspected September 15, 2026.
Company Profile
This profile covers Sanofi Winthrop Industrie based in Marcy-L'Etoile, France.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Unclassified
- 3
- Form 483s
- 4
- Warning letters
- 1
First inspected April 2, 2010. Last inspected September 15, 2026.
Most cited issue areas
- Validation lacking for sterile drug products1 inspection
- Written record of investigation incomplete1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 15, 2026 | Not classified | Biologics · Vaccines and Allergenic Products | 1336872 |
| September 29, 2023 | VAI | Biologics · Vaccines and Allergenic Products | 1221498 |
| March 22, 2019 | Not classified | Biologics | 1089715 |
| September 27, 2017 | Not classified | Biologics | 1028373 |
| September 25, 2015 | VAI | Biologics · Vaccines and Allergenic Products | 945414 |
| June 21, 2013 | VAI | Biologics · Vaccines and Allergenic Products | 838673 |
| April 2, 2010 | VAI | Biologics · Vaccines and Allergenic Products | 661005 |
FDA documents
Warning Letters (1)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sanofi Winthrop Industrie
FEI Number
3002972083
Address
1541 Avenue Marcel Merieux, Marcy-L'Etoile, France
Country
France
ID: 851434de-295b-430d-b638-f2e9f50b0531