Company
FranceSanofi Winthrop Industrie, Le Trait, France – FDA Inspections
Inspection records and compliance data for Sanofi Winthrop Industrie in Le Trait. 12 FDA inspections on record, 4 Form 483s, last inspected September 24, 2026.
Company Profile
This profile covers Sanofi Winthrop Industrie based in Le Trait, France.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 7
- NAI
- 1
- Unclassified
- 4
- Form 483s
- 4
- Warning letters
- 0
First inspected November 30, 2010. Last inspected September 24, 2026.
Most cited issue areas
- Batch production and Batch Control Record Requirements1 inspection
- Investigations of discrepancies, failures1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 24, 2026 | Not classified | Biologics · Vaccines and Allergenic Products | 1337194 |
| April 25, 2023 | VAI | Biologics, Human Drugs · Vaccines and Allergenic Products | 1206033 |
| February 7, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1133485 |
| March 1, 2019 | Not classified | Human Drugs | 1086137 |
| May 25, 2018 | Not classified | Biologics | 1058039 |
| February 14, 2017 | Not classified | Human Drugs | 1001237 |
| July 19, 2016 | VAI | Biologics, Human Drugs · Vaccines and Allergenic Products | 981020 |
| April 9, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 925345 |
| March 28, 2014 | VAI | Human Drugs · Drug Quality Assurance | 872369 |
| January 20, 2014 | VAI | Biologics · Vaccines and Allergenic Products | 874555 |
| September 28, 2012 | VAI | Biologics, Human Drugs · Drug Quality Assurance | 811318 |
| November 30, 2010 | VAI | Human Drugs · Drug Quality Assurance | 706494 |
FDA documents
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Company Information
Name
Sanofi Winthrop Industrie
FEI Number
3003259844
Address
1051 Boulevard Industriel, Le Trait, France
Country
France
ID: c811b5aa-08fe-4a09-ae00-f302ada6f489