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

FUJIFILM Diosynth Biotechnologies Texas, LLC, a biologic drug substance manufacturer in College Station, TX, received a Form 483 with nine observations. The inspection revealed significant deficiencies including inadequate cross-contamination controls, insufficient batch contamination investigations, and a lack of equipment qualification data. Other issues involved failures in data integrity assessments, non-adherence to contamination control strategies, missing cell bank testing procedures, inaccurate inventory management, and deficiencies in work order trending and employee training.