FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Jun 15, 2018
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on June 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 11956d30-0e73-471f-a329-e5f49b00ed65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055737
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Sanofi Winthrop Industrie
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1265031 - 2023-01-27
- FDA Inspection 1124660 - 2019-10-10
- FDA Inspection 881164 - 2014-06-06
- FDA Inspection 783996 - 2012-03-23
- FDA Inspection 659770 - 2010-04-29
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