FDA EIR - Baxter Oncology GmbH - August 27, 2024

An FDA inspection of Baxter Oncology GmbH, located in Halle (Westf.), Germany, was conducted from August 19 to August 27, 2024. The inspection, carried out by CDER/OP, focused on the company's drug product manufacturing processes, including quality, facility and equipment, production, material, and laboratory systems.At the conclusion of the inspection, a 6-item Form FDA 483 was issued, highlighting several significant observations. Key issues included a failure to establish adequate process, procedural controls, and testing to ensure drug product identity, strength, quality, and purity. Deficiencies were also noted regarding the unavailability of calibration specifications for drug product manufacturing, unclear drug substance storage requirements, and an inadequate validation process. Furthermore, standard operating procedures for drug product manufacturing were found to be either deficient or not followed, and facilities and equipment were not adequately maintained.These observations indicate a need for the firm to enhance its adherence to Good Manufacturing Practices (GMP). The final district decision was "Voluntary Action Indicated (VAI)," meaning Baxter Oncology GmbH is expected to address these deficiencies proactively to ensure compliance with regulatory standards for drug product manufacturing.