FDA 483 - Wuxi Apptec Suzhou Co.,Ltd - March 08, 2019

During an inspection of WuXi AppTec (Suzhou) Co., Ltd., a nonclinical laboratory, the FDA observed two significant issues. The firm failed to test the uniformity of test article mixtures and its quality assurance unit did not properly determine whether deviations from approved protocols were authorized and documented. These observations indicate deficiencies in study conduct and quality oversight.