FDA 483 - Shian Jia Meei Enterprise Co., Ltd. - September 05, 2024

Shian Jia Meei Enterprise Co., Ltd. in Tainan City, Taiwan, a medical device manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures in design control, corrective and preventive actions, complaint handling, finished device acceptance, process controls, and labeling activities. The firm also failed to ensure medical device labels bore a Unique Device Identifier (UDI).