FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on September 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · e223c341-6ac9-4148-a1b9-a801e6d50a9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109449
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Sanofi Winthrop Industrie
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2019 | Not classified | Office of Inspections and Investigations | |
| April 27, 2018 | Not classified | Office of Inspections and Investigations | |
| March 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1245906 - 2023-05-12
- FDA Inspection 1112350 - 2019-07-02
- FDA Inspection 1053482 - 2018-04-27
- FDA Inspection 1009805 - 2017-03-03
- FDA Inspection 873415 - 2014-03-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.