Baxter International Inc.
FDA inspection history across 2 sites, 2014 to 2026
- 4
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2014: one warning letter; 2015: two Form 483s; 2023: one Form 483; 2024: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15Two Form 483s and one warning letter, at Deerfield, Illinois and Round Lake, Illinois.
- 2023–26Two Form 483s and one warning letter, at Round Lake, Illinois and Deerfield, Illinois.
- 2024The longest 483 on file: 5 observations over 10 pages at Round Lake, Illinois.
Cited most
Across all Baxter International observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 820.30Design controls2
- 21 CFR 211.25Personnel qualifications1
The complete Baxter International file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Round Lake, Illinois
Four Form 483s · 2015 to 2024 · 12 observations
Latest: Form 483, Aug 1, 2024 →Deerfield, Illinois
Two warning letters · 2014 to 2026
Latest: Warning letter, Sep 29, 2026 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-09-29 | Warning letter Warning letter | Deerfield, Illinois | — | $99 |
| 2024-08-01 | 483 Form 483 | Round Lake, Illinois | 5 | $99 |
| 2023-08-18 | 483 Form 483 | Round Lake, Illinois | 1 | $99 |
| 2015-07-07 | 483 Form 483 | Round Lake, Illinois | 3 | $99 |
| 2015-06-19 | 483 Form 483 | Round Lake, Illinois | 3 | $99 |
| 2014-01-17 | Warning letter Warning letter | Deerfield, Illinois | — | $99 |
Investigators on these documents
Christopher D. Leach (1)David Gasparovich (1)Jesse A. Vazquez (1)Simone E. Pitts (1)Thispage Monica E. Murie (1)
FEI number 1416980 · most recent document Sep 29, 2026
About Baxter International Inc.
How many FDA Form 483s has Baxter International Inc. received?
FDA Intel has 4 Form 483s on file for Baxter International Inc.; the most recent is dated Aug 1, 2024.
When was Baxter International Inc. last inspected by FDA?
The most recent FDA inspection document on file for Baxter International Inc. is a Form 483 dated Aug 1, 2024, for the site in Round Lake, Illinois.
What did FDA cite at Baxter International Inc.?
The regulations cited most in the observations on file for Baxter International Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.165 (Testing and release for distribution), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.
Has Baxter International Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Baxter International Inc.; the most recent is dated Sep 29, 2026.