FDA 483 - Unknown Company - November 26, 2025

This FDA Form 483 summarizes an inspection of Baxalta US Inc. in Round Lake, Illinois, conducted from October 27 to November 26, 2025. The investigators identified several significant failures in the firm’s quality control and manufacturing processes for its product, Flexbumin. Key issues included the quality unit’s failure to adequately investigate and evaluate environmental monitoring recoveries, specifically regarding suspected cross-contamination and false positive results. The facility lacked validated analytical methods to detect certain contaminants and failed to conduct thorough risk assessments concerning personnel movement and shared equipment. Additionally, the FDA found that Baxalta did not adequately address recurring quality discrepancies, such as particulate matter in finished products. Corrective and preventive actions (CAPAs) were frequently delayed or ineffective. Other violations involved inadequate laboratory controls, failure to document production deviations as they occurred, and poor maintenance of equipment used in the manufacturing process. These observations were recorded under the authority of the Federal Food, Drug, and Cosmetic Act to assist the firm in reaching compliance with safety and quality standards. Baxalta is expected to implement corrective actions to address these deficiencies, improve documentation practices, and ensure that all manufacturing processes are supported by scientifically sound procedures and thorough investigations into quality deviations.