Company
FranceSanofi Winthrop Industrie, Maisons Alfort, France – FDA Inspections
Inspection records and compliance data for Sanofi Winthrop Industrie in Maisons Alfort. 5 FDA inspections on record, 1 Form 483, last inspected December 03, 2021.
Company Profile
This profile covers Sanofi Winthrop Industrie based in Maisons Alfort, France.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected December 10, 2010. Last inspected December 3, 2021.
Most cited issue areas
- Changes to Procedures Not Reviewed, Approved1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Defined areas of adequate size for operations1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 3, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1181600 |
| October 31, 2016 | VAI | Human Drugs · Drug Quality Assurance | 992633 |
| November 21, 2014 | NAI | Human Drugs · Drug Quality Assurance | 904598 |
| September 18, 2012 | VAI | Human Drugs · Drug Quality Assurance | 812463 |
| December 10, 2010 | VAI | Human Drugs · Drug Quality Assurance | 705370 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sanofi Winthrop Industrie
FEI Number
1000610805
Address
180 rue Jean Jaures, Maisons Alfort, France
Country
France
ID: 5ef8f321-cafb-4bc0-b099-0ca70a2cc754