Sanofi Winthrop Industrie — FDA Facility Profile
Sanofi Winthrop Industrie is an FDA-registered facility (FEI 3003259844) located in Le Trait, FR. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 25, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (7 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Form 483 and inspection documents
- 1 in FDA's reading room
- Import refusals
- 8
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 25, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 7, 2020 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 19, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 9, 2015 | No Action Indicated (NAI) | No citations listed |
| Mar 28, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 20, 2014 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 28, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Nov 30, 2010 | Voluntary Action Indicated (VAI) | No citations listed |
Form 483s and inspection documents
- Jul 19, 2016: 483 on FDA.gov
Facility details
- Company
- Sanofi Winthrop Industrie
- Location
- Le Trait (FR)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK; STERILIZE
- Source
- decrs