FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Oct 31, 2016
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on October 31, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c42a7191-0052-460d-99e8-cbd76e5fd5bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992633
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Sanofi Winthrop Industrie
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1181600 - 2021-12-03
- FDA Inspection 904598 - 2014-11-21
- FDA Inspection 812463 - 2012-09-18
- FDA Inspection 705370 - 2010-12-10
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