# FDA 483 - Baxter Oncology GmbH - November 05, 2019

Source: https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/f8379713-5f2d-4c65-9d44-6d8d24e6bc75

> FDA 483 for Baxter Oncology GmbH on November 05, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Baxter Oncology GmbH
- Inspection Date: 2019-11-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Baxter Oncology GmbH in Halle (Westf.), Germany, revealed significant deficiencies across multiple areas of drug product manufacturing. Key issues included failures in aseptic processing procedures, inadequate quality control oversight, and insufficient validation of cleaning processes, visual inspection, and critical utilities. The firm also demonstrated a lack of established accuracy for test methods and inadequate protection for electronic data acquisition systems.

## Related Documents

- [483 - 2018-06-14](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/45f622cd-5fa3-459c-95b0-544a8450e0d7)
- [483 - 2018-08-20](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/44a76868-527b-4e97-8b39-bf984e859eb6)
- [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)
- [483 - 2025-09-18](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/32f7c539-e5e8-476d-a76c-af73f8619534)

## Related Officers

- [Virginia A. Carroll](https://www.globalkeysolutions.net/people/virginia-a-carroll/180e8c1a-1712-4701-9399-9758573ef8d8)
- [Zhong Li](https://www.globalkeysolutions.net/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd