FDA 483 - Novo Nordisk US Bio Production Inc. - July 25, 2023

Novo Nordisk US Bio Production Inc. in West Lebanon, NH, a biologic bulk drug substance manufacturer, was cited for significant deficiencies across three observations. The inspection revealed failures in equipment cleaning and sanitization leading to persistent microbial contamination and biofilm issues, inadequate controls over computerized systems resulting in data integrity concerns, and systemic problems with employee training for CGMP functions. These findings indicate a lack of control over critical manufacturing processes and quality systems.