FDA 483 - Wuxi Biologics Co Ltd - June 04, 2024

WuXi Biologics, a drug substance and drug product manufacturer in Wuxi, Jiangsu, was cited for two observations during an FDA inspection. The firm's performance qualification for a packaging machine was found inadequate, as container closure integrity at higher pressures was not demonstrated, potentially compromising vial integrity. Additionally, in-process control testing for drug products utilized insufficient sample sizes, raising concerns about batch consistency and overall product integrity.