Overview
- 17 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-07.
At a glance
Inspections
17
Form 483s
9
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 29 Oct 2025 – 7 Nov 2025 | Biologics | Clean | |
| 22 May 2023 – 31 May 2023 | Biologics | 483 | On file |
| 23 Oct 2018 – 2 Nov 2018 | Biologics | 483 | On file |
| 6 Dec 2016 – 13 Dec 2016 | Biologics | 483 | On file |
| 20 Jun 2016 – 24 Jun 2016 | Biologics | 483 | On file |
| 28 Sep 2015 – 1 Oct 2015 | Biologics | Clean | |
| 3 Mar 2015 – 13 Mar 2015 | Biologics | 483 | On file |
| 20 Sep 2012 | Not recorded | 483 | On file |
| 27 Aug 2010 | Not recorded | 483 | On file |
| 22 Apr 2009 | Not recorded | Clean | |
| 14 Nov 2008 | Not recorded | 483 | On file |
| 7 Nov 2008 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Gene D Arcy3 insp.
Omotunde O Osunsanmi3 insp.
Burnell M Henry2 insp.
Eileen A Liu1 insp.
Jennifer L Reed1 insp.
Laurel A Beer1 insp.
Abby L Mozeke-Baker1 insp.
Prabhu P Raju1 insp.
Randa Melhem1 insp.
Deborah M Trout1 insp.
Joan Johnson1 insp.
Yasamin Ameri1 insp.
Mihaly S Ligmond1 insp.
Toyin B Oladimeji1 insp.
Joan A Loreng1 insp.
Paula A Trost1 insp.
Nancy T Waites1 insp.
Joseph George1 insp.
Full site report
Get the verbatim findings behind Baxalta US Incorporated's 9 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