483
Baxter Oncology GmbHBaxter Oncology GmbH – FDA 483, Sep 26, 2025
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.
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ID · 0d86bbfe-7f41-475c-961e-6a5a661fc1f6
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