FDA 483 - AGC Biologics, Inc. - April 18, 2025

An FDA inspection of AGC Biologics, Inc. in Bothell, WA, a drug substance manufacturer, revealed significant deficiencies in laboratory data management and critical material inventory. Observations included inadequate review of laboratory data, the ability for analysts to delete electronic raw data, and instrument qualification lacking acceptance criteria. Additionally, the firm's inventory system for working cell banks was found to be inaccurate, with no established procedures for conducting inventory counts.