Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-12-03.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Nov 2021 – 3 Dec 2021 | Human Drugs | Clean | |
| 24 Oct 2016 – 31 Oct 2016 | Human Drugs | 483 | View 483 → |
| 13 Nov 2014 – 21 Nov 2014 | Human Drugs | Clean | |
| 18 Sep 2012 | Not recorded | 483 | View 483 → |
| 10 Dec 2010 | Not recorded | 483 | On file |
| 30 Apr 2007 | Not recorded | Clean | |
| 27 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Oct 2016
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Satheesh Thomas, Xiaoping Guan
31 Oct 2016
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Satheesh Thomas, Xiaoping Guan
Investigators
FDA investigators tied to this site in the record.
MRA McCulloughJ1 insp.
Satheesh Thomas1 insp.
Xiaoping Guan1 insp.
Steven M Weinman1 insp.
Shirley J Berryman1 insp.
Ramon E Martinez1 insp.
Yumi J Hiramine1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanofi Winthrop Industrie's 3 Form 483s
Verbatim observations and recurring CFR citations, 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