Overview
- 15 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-18.
At a glance
Inspections
15
Form 483s
9
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Sep 2025 – 18 Sep 2025 | Biologics | 483 | View 483 → |
| 29 Mar 2022 – 7 Apr 2022 | Biologics | 483 | View 483 → |
| 8 Jan 2020 – 17 Jan 2020 | Biologics | 483 | On file |
| 8 Jan 2018 – 19 Jan 2018 | Biologics | 483 | On file |
| 2 Mar 2016 – 10 Mar 2016 | Biologics | 483 | On file |
| 19 Feb 2014 – 28 Feb 2014 | Biologics | 483 | On file |
| 11 Aug 2011 | Not recorded | 483 | On file |
| 12 Aug 2009 | Not recorded | 483 | On file |
| 15 May 2009 | Not recorded | 483 | On file |
| 2 Nov 2007 | Not recorded | Clean | |
| 11 Aug 2005 | Not recorded | Clean | |
| 18 Apr 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Sep 2025
21 CFR 211.188(b)(2)
Identification of Equipment and Lines
Cited by Gene D Arcy, Alan L Truong
7 Apr 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Omotunde O Osunsanmi, Linda Thai, Lewis K Antwi
7 Apr 2022
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Omotunde O Osunsanmi, Linda Thai, Lewis K Antwi
Investigators
FDA investigators tied to this site in the record.
Omotunde O Osunsanmi4 insp.
Gene D Arcy2 insp.
Alan L Truong1 insp.
Linda Thai1 insp.
Lewis K Antwi1 insp.
Eileen A Liu1 insp.
Natalya M Ananyeva1 insp.
Svetlana A Shestopal1 insp.
Aikaterini Alexaki1 insp.
Chava Kimchi Sarfaty1 insp.
Simone E Pitts1 insp.
Michele L Forster1 insp.
Burnell M Henry1 insp.
Jacqueline M Diaz Albert1 insp.
Paula A Trost1 insp.
Joyce A Rockwell1 insp.
Rebecca K Olin1 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 | 1x |
| 21 CFR 211.188(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Baxalta US Inc.'s 9 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