Novo Nordisk US Bio Production Inc. – FDA 483, Dec 9, 2025

NovoNordisk US Bio Production, Inc. in West Lebanon, New Hampshire, was inspected for Active Pharmaceutical Ingredient (API) manufacture and received a Form 483 with five observations. The inspection revealed significant issues including inadequate process validation, failures in the quality unit's oversight of CGMP compliance, insufficient cleaning and sanitization practices, and deficiencies in laboratory test procedures and microbial contamination control. These findings indicate a moderate to severe level of non-compliance with manufacturing and quality standards for drug substances intended for sterile finished drug products.