FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - March 27, 2026

This report details findings from an FDA inspection of Fujifilm Diosynth Biotechnologies USA Inc., conducted between March 23 and March 27, 2026, at its facility in Research Triangle Park, North Carolina. The inspection identified several significant issues concerning microbial control and quality oversight during the manufacture of drug substances intended for sterile injectables. The primary violations include a failure to maintain a sanitary environment, evidenced by the repeated recovery of mold and spore-forming bacteria in production areas. Despite multiple batch rejections due to contamination, the company failed to identify root causes or implement effective corrective actions. Additionally, the firm utilized non-sterile cleaning agents in high-grade cleanrooms and conducted insufficient environmental monitoring. Investigators also noted systemic failures in responding to water system contamination involving biofilm-forming organisms. The company did not adequately assess the risks these organisms posed to product safety or verify that its sanitization procedures were effective. Furthermore, the laboratory"s testing methods were not properly validated to ensure they could detect the specific contaminants found within the facility. These observations were issued under the authority of the Federal Food, Drug, and Cosmetic Act. Fujifilm Diosynth Biotechnologies is required to submit a detailed response to the FDA outlining its planned corrective and preventive measures to address these safety and quality deficiencies.