Company
GermanyBaxter Oncology GmbH, Halle (Westf.), Germany – FDA Inspections
Inspection records and compliance data for Baxter Oncology GmbH in Halle (Westf.). 12 FDA inspections on record (1 OAI), 4 Form 483s, last inspected September 26, 2025.
Company Profile
This profile covers Baxter Oncology GmbH based in Halle (Westf.), Germany.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 1
- VAI
- 4
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 4
- Warning letters
- 0
First inspected July 22, 2010. Last inspected September 26, 2025.
Most cited issue areas
- Environmental Monitoring System2 inspections
- Validation lacking for sterile drug products2 inspections
- Absence of Written Procedures1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1283802 |
| August 27, 2024 | Not classified | Human Drugs | 1249702 |
| May 3, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1206312 |
| January 29, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1161093 |
| September 3, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1106642 |
| June 14, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1056958 |
| June 27, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1019700 |
| March 18, 2016 | VAI | Human Drugs · Drug Quality Assurance | 967376 |
| July 1, 2014 | NAI | Human Drugs · Drug Quality Assurance | 888909 |
| July 20, 2013 | NAI | Human Drugs · Drug Quality Assurance | 845264 |
| August 26, 2011 | NAI | Human Drugs · Drug Quality Assurance | 747007 |
| July 22, 2010 | NAI | Human Drugs · Drug Quality Assurance | 681781 |
FDA documents
Other regulators (1)
- Health Canada · 6 inspections · last November 10, 2022
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Baxter Oncology GmbH
FEI Number
3002806419
Address
Kantstr. 2, Halle (Westf.), Germany
Country
Germany
ID: 43dd5bdb-ca73-4678-ba1f-6ef4b5400e06