FDA 483 - Novo Nordisk Pharmaceutical Industries LP - July 06, 2023
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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.
ID · 281bc5eb-3b36-4b84-8126-0d6364b9f962