FDA 483 - Wuxi Apptec Suzhou Co.,Ltd

WuXi AppTec, a nonclinical laboratory in Suzhou, China, was inspected by the FDA, resulting in two observations. The inspection revealed issues with facility maintenance, including peeled paint and corrosion on HEPA filter covers in several laboratory rooms. Additionally, the quality assurance unit failed to ensure proper documentation of deviations, specifically regarding unlabeled bedding materials in storage.