Baxalta US Inc.
FDA inspection history across 2 sites, 2020 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–22Two Form 483s, at THOUSAND OAKS, California.
- 2020The longest 483 on file: 11 observations over 11 pages at THOUSAND OAKS, California.
- 2025One Form 483, at Thou sand Oak s, California.
Cited most
Across all Baxalta US observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.192Production record review4
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.188Batch production and control records1
The complete Baxalta US file.
All 3 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
THOUSAND OAKS, California
Two Form 483s · 2020 to 2022 · 13 observations
Latest: Form 483, Apr 7, 2022 →Thou sand Oak s, California
One Form 483 · 2025 · 2 observations
Latest: Form 483, Sep 18, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-18 | 483 Form 483 | Thou sand Oak s, California | 2 | $99 |
| 2022-04-07 | 483 Form 483 | THOUSAND OAKS, California | 2 | $99 |
| 2020-01-17 | 483 Form 483 | THOUSAND OAKS, California | 11 | $99 |
Investigators on these documents
Alan L. Truong (1)Eileen A. Liu (1)Gene D. Arcy (1)Lewis K. Antwi (1)Linda Thai (1)S. Sef Svetlana Shestopal (1)
FEI number 1000519965 · most recent document Sep 18, 2025
About Baxalta US Inc.
How many FDA Form 483s has Baxalta US Inc. received?
FDA Intel has 3 Form 483s on file for Baxalta US Inc.; the most recent is dated Sep 18, 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 Sep 18, 2025, for the site in Thou sand Oak s, California.
What did FDA cite at Baxalta US Inc.?
The regulations cited most in the observations on file for Baxalta US Inc. are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.42 (Design and construction features), 2 times.