Overview
- 24 FDA inspections are on record.
- 17 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-06.
At a glance
Inspections
24
Form 483s
17
EIRs
3
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Nov 2025 – 6 Nov 2025 | Biologics | 483 | On file |
| 25 Jul 2024 – 2 Aug 2024 | Biologics | 483 | View 483 → |
| 20 Mar 2023 – 22 Apr 2023 | Human Drugs | 483 | View 483 → |
| 22 Oct 2018 – 26 Oct 2018 | Biologics | 483 | On file |
| 6 Jun 2018 – 15 Jun 2018 | Human Drugs | 483 | On file |
| 14 Jun 2016 – 22 Jun 2016 | Biologics | 483 | On file |
| 29 Apr 2014 – 9 May 2014 | Biologics | 483 | On file |
| 18 Aug 2012 | Not recorded | 483 | On file |
| 26 May 2011 | Not recorded | 483 | On file |
| 18 Nov 2010 | Not recorded | 483 | On file |
| 21 May 2010 | Not recorded | 483 | On file |
| 5 Nov 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jacqueline M Diaz Albert3 insp.
James M Mason2 insp.
Cynthia Jim2 insp.
Paula A Trost2 insp.
Prajakta A Varadkar1 insp.
Shafiq Ahadi1 insp.
Scott T Ballard1 insp.
Edmund F Mrak1 insp.
Dino A Feigelstock1 insp.
Christian Lynch1 insp.
Solomon Yimam1 insp.
Justin A Boyd1 insp.
Nikisha M Bolden1 insp.
Craig D Zagata1 insp.
Prabhu P Raju1 insp.
Michele L Forster1 insp.
Susan M Jackson1 insp.
Donald B Ertel1 insp.
Nicole K Trudel1 insp.
Helen B Ricalde1 insp.
Burnell M Henry1 insp.
Joan A Loreng1 insp.
Sarah B Tanksley1 insp.
Joseph George1 insp.
Marion Michaelis1 insp.
Gang Wang1 insp.
Jennifer L Schmidt1 insp.
Destry M Sillivan1 insp.
Mihaly S Ligmond1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanofi Pasteur Inc.'s 17 Form 483s
Source PDFs 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