Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-09-13.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2019 – 13 Sep 2019 | Human Drugs | 483 | On file |
| 24 Jun 2019 – 2 Jul 2019 | Human Drugs | 483 | On file |
| 19 Apr 2018 – 27 Apr 2018 | Human Drugs | 483 | On file |
| 27 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | On file |
| 3 Mar 2014 – 7 Mar 2014 | Human Drugs | 483 | On file |
| 30 Apr 2010 | Not recorded | 483 | On file |
| 6 Jun 2007 | Not recorded | Clean | |
| 16 Apr 2000 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Joey V Quitania1 insp.
Scott R Nichols1 insp.
Reyes Candau-Chacon1 insp.
Richard Ledwidge1 insp.
Zhong Li1 insp.
Ariel Cruz Figueroa1 insp.
Kenneth G Klobus1 insp.
Michael R Goga1 insp.
Kristy A Zielny1 insp.
Full site report
Get the verbatim findings behind Sanofi Winthrop Industrie's 6 Form 483s
The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat