FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Jul 17, 2018
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on July 17, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 27572d34-8446-4db8-8819-49ecbc085915
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063584
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
Other FDA inspections of Sanofi Winthrop Industrie
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 29, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 25, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 25, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1246180 - 2023-03-10
- FDA Inspection 1118089 - 2019-03-29
- FDA Inspection 1022342 - 2017-07-25
- FDA Inspection 998080 - 2016-09-14
- FDA Inspection 857683 - 2013-10-25
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