WuXi Biologics Achieves FDA PLI Clearance Across Five Sites

• WuXi Biologics has passed U.S. FDA inspections for five manufacturing facilities with no critical issues.

• This brings the company’s total to 42 successful global regulatory inspections, including 22 by the FDA and EMA.

WuXi Biologics, a global CRDMO, announced that five of its manufacturing facilities in Wuxi, China, have successfully passed the U.S. Food and Drug Administration’s Pre-License Inspection (PLI) without any critical issues or data integrity concerns.

The inspections covered the company’s quality management systems and full production processes at two drug substance sites (MFG1 and MFG5) and three drug product sites (DP1, DP2, and DP5). Notably, this includes the initial FDA inspection for DP5, the company’s first commercial pre-filled syringe (PFS) manufacturing facility, which will now support PFS contract manufacturing for clients.

This outcome continues WuXi Biologics’ 100% success rate in FDA PLIs. As of late 2024, the company has passed 42 global inspections, including 22 by the FDA and EMA, and received 97 licence approvals from regulatory agencies worldwide.

Dr. Chris Chen, CEO of WuXi Biologics, stated: “Maintaining a 100% success rate for regulatory inspections is a true reflection of our relentless pursuit of excellence in building a world-class quality system that not only meets but exceeds global regulatory requirements.”