FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Nov 3, 2023
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on November 3, 2023, issued by the Office of Inspections and Investigations.
- Company
- Sanofi Winthrop Industrie
- Inspection Date
- November 3, 2023
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ID · 42f4563f-62b6-4252-b72d-a981f20bca41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1221763
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Sanofi Winthrop Industrie
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1267532 - 2023-11-22
- FDA Inspection 1094501 - 2018-04-20
- FDA Inspection 861974 - 2013-12-06
- FDA Inspection 753776 - 2011-11-04
- FDA Inspection 560525 - 2009-01-23
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