FDA 483 - AGC Biologics A/S - November 05, 2019

An FDA inspection of AGC Biologics A/S in Soeborg, Denmark, revealed significant deficiencies across manufacturing, quality assurance, and laboratory operations. The firm failed to follow master batch records, adequately investigate recurring deviations, implement corrective actions, and maintain scientifically sound laboratory controls. These issues indicate a lack of robust quality systems and control over drug substance manufacturing processes.