FDA 483 - SGS-CSTC Standards Technical Services (Shanghai) Co., Ltd. - March 23, 2019

The FDA inspection of SGS-CSTC Standards Technical Services Co., Ltd. in Shanghai, a contract testing laboratory, revealed significant deficiencies in their quality control systems. The firm failed to adequately investigate out-of-specification (OOS) results and deviations, often invalidating results without scientific justification or leaving investigations incomplete. Furthermore, the accuracy, sensitivity, specificity, and reproducibility of their test methods were not properly established and documented.