FDA 483 - CSL Behring GmbH - February 18, 2026

CSL Behring GmbH, located in Marburg, Germany, underwent an FDA inspection from February 9 to February 18, 2026. The inspection of this licensed biological drug manufacturer revealed several significant violations of quality and safety standards across multiple marketed products, including Haegarda, Kcentra, and Humate-P. A primary concern involved an unverified change to the material of vial stoppers. The company failed to perform necessary compatibility studies to ensure the new material worked with medical transfer devices. This oversight led to a significant increase in global complaints where patients were unable to puncture the stoppers, resulting in bent device spikes, treatment delays, and dosing errors. Despite internal data confirming the material change was the root cause, the firm failed to report these biological product deviations to the FDA as required. Additionally, the FDA noted deficiencies in complaint management and manufacturing hygiene. The company frequently downplayed the severity of patient issues and delayed corrective actions for years. Investigators also found that the firm failed to re-validate equipment cleaning procedures after experiencing bacterial contamination in the production line. Finally, the quality unit was cited for excessive delays in closing internal investigations. Under the regulatory framework of the Food, Drug, and Cosmetic Act, these observations require CSL Behring to implement comprehensive corrective actions. The firm is expected to respond to the FDA with a plan to resolve these deficiencies to ensure compliance with drug safety and manufacturing standards.