BAXALTA US INC.
Form 483 issued November 26, 2025 · Round Lake, Illinois
- Inspection
- Oct 27 – Nov 26, 2025
- Investigators
- Peng Zhou· Shafig Ahadi
- Observations
- 1
- Pages
- 9
- FEI number
- 3012385969
In short: On November 26, 2025, FDA issued a Form 483 with 1 observation to BAXALTA US INC. in Round Lake, Illinois (FEI 3012385969) after an inspection that ran Oct 27 – Nov 26, 2025. The investigators were Peng Zhou and Shafig Ahadi. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not fully followed. A. Since…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmBAXALTA US INC. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BAXALTA US INC.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected BAXALTA US INC.?
Peng Zhou and Shafig Ahadi are named on this Form 483, for the inspection of Oct 27 – Nov 26, 2025. Each investigator has a profile showing what they cite most.
When was BAXALTA US INC. inspected by FDA?
The inspection ran Oct 27 – Nov 26, 2025, and the Form 483 is dated November 26, 2025.
How do I get the full Form 483 for BAXALTA US INC.?
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