Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-29.
At a glance
Inspections
11
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Mar 2019 – 29 Mar 2019 | Human Drugs | Clean | |
| 9 Jul 2018 – 17 Jul 2018 | Biologics | 483 | On file |
| 17 Jul 2017 – 25 Jul 2017 | Human Drugs | 483 | On file |
| 7 Sep 2016 – 14 Sep 2016 | Biologics | 483 | On file |
| 22 Feb 2016 – 26 Feb 2016 | Human Drugs | 483 | On file |
| 12 May 2014 – 16 May 2014 | Biologics | 483 | On file |
| 17 Oct 2013 – 25 Oct 2013 | Human Drugs | Clean | |
| 29 Sep 2011 | Not recorded | 483 | On file |
| 17 Sep 2009 | Not recorded | Clean | |
| 13 Mar 2008 | Not recorded | 483 | On file |
| 2 Jul 2003 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Burnell M Henry1 insp.
Jose E Melendez1 insp.
Debra M Emerson1 insp.
Cynthia Jim1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Donald B Ertel1 insp.
Linda Thai1 insp.
Helen B Ricalde1 insp.
Azza Talaat1 insp.
Susan F Laska1 insp.
Full site report
Get the verbatim findings behind Sanofi Winthrop Industrie's 7 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