Novo Nordisk A/S - G8, X9 M.FI – FDA 483, Apr 17, 2026

An FDA inspection of Novo Nordisk's biopharmaceutical facility in Malov, Denmark, identified two observations concerning method validation activities for a drug product. The firm was cited for insufficient documentation of method validation activities, specifically regarding stability evaluations, and for failing to consistently adhere to established standard operating procedures during method validation experiments. These findings suggest potential gaps in the firm's quality control and data integrity practices.