FDA 483 - Novo Nordisk Pharmaceutical Industries LP - August 29, 2024

Novo Nordisk Pharmaceutical Industries LP in Durham, NC, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate environmental controls for API storage, a lack of a comprehensive stability testing program, and insufficient hold time studies. Additionally, the firm failed to follow written procedures for blending alarms, demonstrated inadequate quality control oversight, and had an insufficient shipping validation for its Semaglutide API.