FDA 483 - Novo Nordisk Pharmaceutical Industries LP - May 09, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Novo Nordisk Pharmaceutical Industries, LP in Clayton, NC, a non-sterile API manufacturer, was cited for three observations during an FDA inspection. The findings included a failure to identify Burkholderia cepacia as an objectionable organism, inadequate cleaning validation and routine cleaning for production equipment, and a lack of written procedures for instrument component traceability and maintenance tags. These issues indicate deficiencies in contamination control and quality system procedures.
ID · 83be62a1-a352-4d5a-a220-8eb28ceb43b9