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 Vaccines US 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