FDA 483 - AGC Biologics, Inc. - March 19, 2021

An FDA inspection of AGC Biologics Inc. in Bothell, WA, a drug substance manufacturer, revealed significant deficiencies across its manufacturing, quality control, and facility maintenance operations. Key issues included unapproved manufacturing steps, inadequate computerized system configurations, and failures in out-of-specification investigations. The firm also exhibited poor documentation practices, unaddressed equipment repairs, and inadequate validations, indicating a lack of robust quality systems and control over critical processes.