Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-26.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2025 – 26 Nov 2025 | Biologics | 483 | View 483 → |
| 8 Sep 2022 – 15 Sep 2022 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Nov 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Shafiq Ahadi, Peng Zhou
26 Nov 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Shafiq Ahadi, Peng Zhou
26 Nov 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Shafiq Ahadi, Peng Zhou
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BAXALTA US INC.'s 2 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