Amgen, Inc. – FDA 483, Feb 6, 2024

Amgen Inc. in Thousand Oaks, CA, was cited for significant deficiencies during an FDA inspection. Observations included poor aseptic processing techniques, inadequate environmental monitoring, and insufficient smoke studies in sterile drug product manufacturing. Additionally, the firm's documentation practices, cross-contamination prevention, electronic data system controls, and quality unit oversight were found to be inadequate.