FDA 483 - Baxter Oncology GmbH - November 05, 2019

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.