FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Sep 15, 2026
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on September 15, 2026, issued by the Office of Inspections and Investigations, covering biologics.
- Company
- Sanofi Winthrop Industrie
- Inspection Date
- September 15, 2026
- Product Type
- Biologics
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ID · d4092ca8-ed3b-442b-9a90-d88568b48573
Inspection Facts
- Inspection number
- 1336872
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Sanofi Winthrop Industrie
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 22, 2019 | Not classified | Office of Inspections and Investigations | |
| September 27, 2017 | Not classified | Office of Inspections and Investigations | |
| September 25, 2015 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 21, 2013 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1221498 - 2023-09-29
- FDA Inspection 1089715 - 2019-03-22
- FDA Inspection 1028373 - 2017-09-27
- FDA Inspection 945414 - 2015-09-25
- FDA Inspection 838673 - 2013-06-21
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