AGC Biologics, Inc. – FDA 483, Feb 10, 2023

The FDA inspection of AGC Biologics Inc. in Bothell, WA, revealed significant deficiencies in their drug substance manufacturing. The firm failed to conduct prompt and thorough deviation investigations, lacked adequate controls for electronic data, and demonstrated insufficient measures to prevent contamination. Additionally, standard operating procedures were often not followed or were inadequate, and the quality unit exhibited poor oversight of GMP operations.