BAXALTA US INC.
FDA inspection history across 2 sites, 2022 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at ROUND LAKE, Illinois.
- 2022The longest 483 on file: 3 observations over 3 pages at ROUND LAKE, Illinois.
- 2025One Form 483, at Round Lake, Illinois.
Cited most
Across all BAXALTA US observations on file
- 21 CFR 211.84(d)(3)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete BAXALTA US file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Round Lake, Illinois
One Form 483 · 2025 · 1 observation
Latest: Form 483, Nov 26, 2025 →ROUND LAKE, Illinois
One Form 483 · 2022 · 3 observations
Latest: Form 483, Sep 15, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-26 | 483 Form 483 | Round Lake, Illinois | 1 | $99 |
| 2022-09-15 | 483 Form 483 | ROUND LAKE, Illinois | 3 | $99 |
Investigators on these documents
FEI number 3012385969 · most recent document Nov 26, 2025
About BAXALTA US INC.
How many FDA Form 483s has BAXALTA US INC. received?
FDA Intel has 2 Form 483s on file for BAXALTA US INC.; the most recent is dated Nov 26, 2025.
When was BAXALTA US INC. last inspected by FDA?
The most recent FDA inspection document on file for BAXALTA US INC. is a Form 483 dated Nov 26, 2025, for the site in Round Lake, Illinois.
What did FDA cite at BAXALTA US INC.?
The regulations cited most in the observations on file for BAXALTA US INC. are 21 CFR 211.84(d)(3) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.