WuXi AppTec’s Lab Testing Division’s Bioanalytical facility in Shanghai has passed U.S. FDA’s bioequivalence (BE) inspection with no 483 observations.

The FDA inspectors audited WuXi’s quality system during the 5-day inspection, focusing on scientific data integrity, operation infrastructure, equipment, sample storage, archival system, quality control, and quality assurance. The inspection covered two bioequivalence studies for pre-approval including method validation and sample analysis and eight other clinical bioanalytical studies from 2013 and 2016 as a general regulatory compliance inspection.

“FDA has the most stringent requirement on quality and data integrity among international regulatory agencies. We are proud with the result of this audit,” says Dr. Jason Liu, Senior Vice President and Chief Operating Officer of Lab Testing Division. “We will continue to maintain the highest quality standards, and provide the best-in-class R&D services for our customers worldwide.”
 
WuXi AppTec provides small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and molecular testing and genomics.