Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-21.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Aug 2019 – 21 Aug 2019 | Human Drugs | Clean | |
| 11 Sep 2017 – 14 Sep 2017 | Human Drugs | Clean | |
| 1 Aug 2017 – 11 Aug 2017 | Human Drugs | 483 | On file |
| 16 Sep 2014 – 25 Sep 2014 | Human Drugs | 483 | View 483 → |
| 13 Nov 2009 | Not recorded | 483 | On file |
| 28 May 2009 | Not recorded | Clean | |
| 10 Oct 2008 | Not recorded | 483 | On file |
| 16 Jul 2007 | Not recorded | Clean | |
| 21 Jan 2005 | Not recorded | Clean | |
| 15 Nov 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Sep 2014
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Rebecca Rodriguez
Investigators
FDA investigators tied to this site in the record.
Debra M Emerson3 insp.
Edmund F Mrak2 insp.
Hugh M Mcclure1 insp.
Haley H Seymour1 insp.
Diane L Raccasi1 insp.
Rebecca Rodriguez1 insp.
Thomas J Arista1 insp.
Kent A Conforti1 insp.
Megan A Haggerty1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanofi Genzyme's 4 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