# FDA 483 - Baxter Oncology GmbH - August 27, 2024

Source: https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/2af708b1-9a7e-4ae2-970f-cadc4ee74ce6

> FDA 483 for Baxter Oncology GmbH on August 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Baxter Oncology GmbH
- Inspection Date: 2024-08-27
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Baxter Oncology GmbH, a drug product manufacturer in Halle Westfalen, was cited for multiple significant deficiencies during an FDA inspection. Observations included failures in aseptic process simulation, uncalibrated manufacturing equipment, unclear drug substance storage, deficient validation, non-adherence to SOPs, and inadequate facility and equipment maintenance, all impacting drug product quality and sterility assurance.

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- [483 - 2024-08-27](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/270239ed-c98e-4bdd-8d78-095067105231)
- [483 - 2025-09-18](https://www.globalkeysolutions.net/records/483/baxter-oncology-gmbh/32f7c539-e5e8-476d-a76c-af73f8619534)

## Related Officers

- [Bingchen Du](https://www.globalkeysolutions.net/people/bingchen-du/2df8f706-844c-46b1-8461-51f0b9f0585b)
- [Sr. Pharm Quality Assessor](https://www.globalkeysolutions.net/people/sudipan-karmaker/9749496b-c89d-4581-babf-02d45d103f83)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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