FDA 483 - Novo Nordisk Pharmaceutical Industries LP - July 06, 2023

Novo Nordisk Pharmaceutical Industries LP in Clayton, NC, an API manufacturer, was cited for significant deficiencies in quality control. The inspection revealed a failure to thoroughly investigate the cause of objectionable organisms found in intermediate Semaglutide API batches and inadequate microbial controls, including a lack of established microbial limits for in-process materials. These issues indicate a serious breakdown in ensuring product quality and safety.