FDA EIR - Novo Nordisk A/S - March 25, 2024

An FDA inspection of Novo Nordisk A/S, a Drug Substance manufacturer located in Kalundborg, Denmark, was conducted on March 15, 18-22, and 25, 2024. The inspection was risk-based and followed regulatory frameworks including ICH Q7 "Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry." At the conclusion of the inspection, an 8-item Form FDA 483 was issued, highlighting significant concerns. Primary violations included insufficient routine sample volume for water system testing and inadequate control over potable and purification water systems for microbial counts. Inspectors also noted that drug substance manufacturing and processing operations were not adequately described or controlled in master production records, and validation data for critical process parameters was incomplete. Furthermore, written procedures designed to assure identity, strength, quality, and purity of drug substances were deemed inadequate. The quality control unit's responsibilities and procedures were not consistently followed, evidenced by missing environmental monitoring samples, and laboratory controls lacked scientifically sound sampling plans for production cultures. Novo Nordisk A/S is required to provide a comprehensive response to the FDA 483 observations, detailing proposed corrective actions and preventive measures to address these manufacturing and quality system deficiencies.