Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-30.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jan 2025 – 30 Jan 2025 | Biologics | Clean | |
| 22 Jun 2021 – 1 Jul 2021 | Biologics | 483 | On file |
| 26 Feb 2018 – 2 Mar 2018 | Biologics | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Alan L Truong1 insp.
Brentley S Pittman1 insp.
Yvesna C Blaise1 insp.
Nimmy Mathews1 insp.
Janet L Bowen1 insp.
Omotunde O Osunsanmi1 insp.
Deborah M Trout1 insp.
Michael C Kennedy1 insp.
Lily Y Koo1 insp.
Yonggang Wang1 insp.
Silvia Wanis1 insp.
Full site report
Get the verbatim findings behind Baxalta US Inc.'s 2 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