Fujifilm’s Holly Springs facility in North Carolina has been selected as one of seven sites for the FDA's PreCheck pilot manufacturing program. The initiative is designed to improve regulatory efficiency by allowing pre-approved facilities to accelerate the review process for new therapies. The Holly Springs site is described as one of North America's largest end-to-end cell culture biopharmaceutical manufacturing facilities and a key component of Fujifilm’s expanding global network.
Details on the other six participants have not been disclosed. The program focuses on facilities with a track record of quality compliance, enabling faster inspections and potential expedited access to the market for contract manufacturing clients. This marks a shift toward risk-based oversight in the biologics supply chain.
The FDA PreCheck program aims to reduce the time between regulatory submission and facility inspection, a common bottleneck for drug approvals. By pre-vetting manufacturing sites, the agency hopes to streamline the launch of new biologic drugs, particularly those addressing urgent public health needs.
For Fujifilm, participation enhances its credibility as a top-tier contract development and manufacturing organization (CDMO). The company has been actively investing in its U.S. manufacturing footprint, with Holly Springs serving as a flagship site for large-scale mammalian cell culture. This selection could attract new clients seeking faster regulatory pathways.
While the program holds promise, skeptics question whether pre-approval audits can fully substitute for pre-license inspections. Some industry analysts note that thorough on-site checks remain essential to catch unforeseen quality issues, particularly as manufacturing processes scale up.