FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - March 11, 2025

During an inspection of Fujifilm Diosynth Biotechnologies Texas, LLC from March 4 to March 11, 2025, the FDA identified several operational and quality control deficiencies at the firm"s College Station facility. The findings, documented in a Form 483, highlight significant issues regarding multi-product manufacturing controls, laboratory procedures, and data integrity. Primary violations include inadequate segregation of manufacturing stages to prevent cross-contamination and poor aseptic techniques, such as leaving containers open and performing tasks without proper masks. The facility’s stability program failed to meet its own timelines, with some internal tests delayed by over 100 days. Additionally, the quality control laboratory lacked validated test procedures, leading to recurring failures in system suitability assessments. The inspection also revealed gaps in electronic data management, specifically a lack of validation for systems used to collect critical process data and insufficient oversight of audit trails. Cleaning protocols were found to be incomplete, failing to specify contact times or cover all representative surfaces. Finally, the quality unit showed insufficient oversight of contractors and inconsistent documentation regarding product hold times. Under the regulatory framework for drug manufacturing, these observations require the company to respond formally to the FDA. The firm must provide a detailed plan for corrective and preventive actions to address these gaps and ensure the facility operates in compliance with safety and quality standards.