Baxter Oncology GmbH
FDA inspection history across 4 sites, 2018 to 2026
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2019: one Form 483; 2024: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Halle/Westfalen, Germany.
- 2024–26Two Form 483s and one warning letter, at Halle Westfalen, Germany; Halle (Westf.), Germany and Parsippany, New Jersey.
- 2025The longest 483 on file: 12 observations over 17 pages at Halle (Westf.), Germany.
Cited most
Across all Baxter Oncology observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.100Written procedures; deviations2
The complete Baxter Oncology file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Halle/Westfalen, Germany
Two Form 483s · 2018 to 2019 · 13 observations
Latest: Form 483, Nov 5, 2019 →Parsippany, New Jersey
One warning letter · 2026
Latest: Warning letter, Mar 3, 2026 →Halle (Westf.), Germany
One Form 483 · 2025 · 12 observations
Latest: Form 483, Sep 26, 2025 →Halle Westfalen, Germany
One Form 483 · 2024 · 6 observations
Latest: Form 483, Aug 27, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-03 | Warning letter Warning letter | Parsippany, New Jersey | — | $99 |
| 2025-09-26 | 483 Form 483 | Halle (Westf.), Germany | 12 | $99 |
| 2024-08-27 | 483 Form 483 | Halle Westfalen, Germany | 6 | $99 |
| 2019-11-05 | 483 Form 483 | Halle/Westfalen, Germany | 9 | $99 |
| 2018-06-14 | 483 Form 483 | Halle/Westfalen, Germany | 4 | $99 |
Investigators on these documents
Bingchen Du (1)Emilie Kahn (1)Justin A. Boyd (1)Karen A. Briggs (1)Luis M. Burges (1)Sudipan Karmaker (1)Virginia A. Carroll (1)Vivin George (1)Wayne Seifert (1)Zhong Li (1)
FEI number 3002806419 · most recent document Mar 3, 2026
About Baxter Oncology GmbH
How many FDA Form 483s has Baxter Oncology GmbH received?
FDA Intel has 4 Form 483s on file for Baxter Oncology GmbH; the most recent is dated Sep 26, 2025.
When was Baxter Oncology GmbH last inspected by FDA?
The most recent FDA inspection document on file for Baxter Oncology GmbH is a Form 483 dated Sep 26, 2025, for the site in Halle (Westf.), Germany.
What did FDA cite at Baxter Oncology GmbH?
The regulations cited most in the observations on file for Baxter Oncology GmbH are 21 CFR 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Baxter Oncology GmbH received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Baxter Oncology GmbH; the most recent is dated Mar 3, 2026.