FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Sep 18, 2012
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on September 18, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sanofi Winthrop Industrie
- Inspection Date
- September 18, 2012
- Product Type
- Drugs
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ID · 86a32330-a206-4c05-a003-2378d5ab7254
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 812463
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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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 |
| October 31, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2014 | NAI | 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 992633 - 2016-10-31
- FDA Inspection 904598 - 2014-11-21
- FDA Inspection 705370 - 2010-12-10
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