FDA 483 - Baxter Oncology GmbH - June 14, 2018

An FDA inspection conducted from June 4-14, 2018, at Baxter Oncology GmbH in Halle (Westf.), North Rhine-Westphalia, identified significant deviations in their manufacturing and quality systems, resulting in a Form FDA 483. The inspection revealed that the company

s process validation for a specific drug product manufacturing process was deficient. This inadequacy led to both a process validation lot and three commercial lots of the drug product failing to meet release specifications, with these commercial lots subsequently distributed to the U.S. market. Issues included inadequate capture of risk analysis and equipment variability in validation protocols. Furthermore, the inspection found that certain manufacturing equipment was not appropriately designed or qualified for its intended use, affecting commercially distributed lots. Batch production records were also cited for being incomplete, lacking documentation for critical manufacturing steps, such as specific timings during processing. Finally, the quality control unit failed to adhere to its stability monitoring program, as a drug product batch was not placed on stability as required in 2015, and this deviation was not documented. Baxter Oncology GmbH is required to address these observations to ensure compliance with regulatory standards.