FDA 483 - Novo Nordisk Pharmaceutical Industries LP - May 09, 2022

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.