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 C...