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 sa...