Fujifilm Biotechnologies’ Holly Springs, North Carolina cell-culture manufacturing site was selected for the FDA’s PreCheck Pilot Program. The program, limited to seven participants, is intended to strengthen FDA-industry engagement by enabling earlier interactions around manufacturing readiness and regulatory predictability. Selection is positioned to support more efficient facility inspections and reduce uncertainty for sponsors relying on the site for biologics and monoclonal antibody production. The company noted that its customers include argenx, Johnson & Johnson, and Regeneron. For CDMO users and manufacturing decision-makers, PreCheck participation signals a path to tighter alignment between quality-by-design plans and inspection expectations ahead of submissions.