# FDA 483 - Baxter Oncology GmbH - September 26, 2025

Source: https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/0d86bbfe-7f41-475c-961e-6a5a661fc1f6

> FDA 483 for Baxter Oncology GmbH on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Oncology GmbH
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: The FDA inspected Baxter Oncology GmbH in Halle (Westf.), Germany, and issued a Form 483 with 12 observations. The inspection revealed significant deficiencies in aseptic processing, sterilization validation, environmental monitoring, quality control, and document management, indicating a high risk of product contamination and quality issues.

## Related Documents

- [483 - 2018-06-14](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/45f622cd-5fa3-459c-95b0-544a8450e0d7)
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- [483 - 2019-11-05](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/f8379713-5f2d-4c65-9d44-6d8d24e6bc75)
- [483 - 2024-08-27](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/270239ed-c98e-4bdd-8d78-095067105231)
- [483 - 2024-08-27](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/2af708b1-9a7e-4ae2-970f-cadc4ee74ce6)

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Investigator](https://www.globalkeysolutions.net/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.globalkeysolutions.net/companies/baxter-oncology-gmbh/43dd5bdb-ca73-4678-ba1f-6ef4b5400e06

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8