We are pleased to announce that WuXi’s  Lab Testing Division(LTD)’s Bioanalytical facility in Shanghai once again passed US FDA’s bioequivalence (BE) inspection with no 483 observations.

The inspectors from FDA thoroughly audited WuXi’s quality system during the five-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.

We are proud of the result of this audit, and will continue to maintain the highest quality standards, and provide the best-in-class R&D services for our customers worldwide.

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