By Fineline Cube 
WuXi Biologics (HKG: 2269) announced on July 21, 2025, that five of its manufacturing facilities successfully passed the U.S. Food and Drug Administration’s (FDA) pre-approval licensing inspection (PLI) without any critical findings or data integrity issues. This achievement underscores the company’s commitment to global regulatory standards and quality excellence.
Inspection Details
The nine-day FDA inspection comprehensively covered WuXi Biologics’ quality management system and the full production processes of two drug substance plants (MFG1 and MFG5) and three drug product plants (DP1, DP2, and DP5) in Wuxi, China. Notably, DP5, the company’s first commercial pre-filled syringe (PFS) filling plant, successfully passed a regulatory inspection for the first time. This milestone highlights WuXi Biologics’ expanding capabilities in advanced drug delivery systems.
Global Compliance Milestones
As of the end of 2024, WuXi Biologics had successfully passed 42 global regulatory inspections and secured 97 manufacturing licenses from regulatory authorities across the U.S., Europe, China, Singapore, Japan, and Canada. These achievements for its 16 global manufacturing sites reflect the company’s robust compliance and quality assurance framework, reinforcing its position as a trusted partner in the global biologics manufacturing landscape.-Fineline Info & Tech