FDA 483 - Global Fabtech Wheelchair (Shanghai) Co., Ltd. - April 04, 2019

An FDA inspection of Global Fabtech Wheelchair (Shanghai) Co. Ltd., a medical device manufacturer, identified two significant issues. The firm failed to adequately document process validation activities for automated welding machines used in scooter frame production. Additionally, procedures for the routine calibration of torque wrenches were not consistently followed, leading to incomplete test results.