WuXi AppTec's Bioanalytical Services (BAS) unit was successfully inspected by the FDA without the issuance of a Form 483. BAS provides GLP-compliant services to analyze small-molecule drugs using liquid chromatography/mass spectroscopy, and to measure biomarker/biologics and antibody immunogenicity using immunochemistry.
In the FDA review, which took place between March 23 and March 27, the entire BAS facility was inspected and two bioequivalency (BE) studies were audited. The SFDA of China sent four investigators to participate as observers.
"We are very pleased to have passed this audit," commented Dr. Ge Li, chairman and chief executive officer of WuXi AppTec. "It represents our company's first audit by U.S. FDA and the first such audit of any bioanalytical laboratory in China. WuXi will continue to pursue the highest levels of quality and transparency to meet and exceed FDA requirements."
"As a GLP-compliant facility, BAS always treats quality and compliance as our highest priorities," commented Dr. Jinsong Xing, executive director of BAS of WuXi AppTec. "We maintain GLP readiness through continuous training, review of technology, and rigorous proficiency testing. Our quality control team thoroughly reviews all data and closely monitors the facility for compliance on a daily basis."