FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - August 31, 2021

An FDA inspection of FUJIFILM Diosynth Biotechnologies Texas, LLC, a biologic drug substance manufacturer, conducted from August 23 to August 31, 2021, resulted in nine inspectional observations. These observations highlight potential deficiencies in the firm's adherence to current Good Manufacturing Practices. Significant issues identified include insufficient controls to prevent cross-contamination, particularly regarding personnel transitions between different viral production environments. The inspection revealed an inadequate investigation into a batch contamination incident, where critical samples from suspect material were not collected. Other concerns involved the absence of quantitative qualification for specific manufacturing equipment, leading to recurring process deviations, and a failure to consistently implement the firm’s established contamination control strategy for media and buffer testing. Further observations detailed inadequate data integrity assessments across analytical instrumentation, a lack of procedures for testing incoming cell banks, and substantial inaccuracies in warehouse labeling and inventory systems. Additionally, the firm did not adequately review and trend maintenance work orders to inform preventative maintenance or requalification needs, and experienced failures in its training system, resulting in unassigned mandatory employee training for updated procedures. FUJIFILM Diosynth Biotechnologies Texas is expected to provide a comprehensive response detailing corrective actions to address these findings.