FDA 483 - Enter Medical Corporation - February 28, 2019

During an inspection of Enter Medical Corporation, a medical device manufacturer in Hsin Kang Township, Chiayi County, Taiwan, the FDA observed a lack of documentation for out-of-calibration equipment and subsequent remedial actions. Specifically, an Air Leakage Test equipment was found to be overdue for calibration. This indicates a moderate severity issue related to quality system controls for equipment maintenance.