Baxter Oncology GmbHSeptember 26, 2025

FDA 483 - Baxter Oncology GmbH - September 26, 2025

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Record Details

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.

Company: Baxter Oncology GmbH
Inspection Date: September 26, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
People: Vivin George
Karen A. Briggs (Investigator)
Justin A. Boyd (Research Specialist II)

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