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483
•Baxter Oncology GmbH•September 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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ID · 0d86bbfe-7f41-475c-961e-6a5a661fc1f6

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