FDA 483 - Xinyu Electronic Co Ltd - March 07, 2019

An FDA inspection of Xinyu Electronic Co Ltd in Zhongshan, Guangdong, China, from March 4-7, 2019, identified one significant observation. The firm failed to validate its soldering operations, a key process in the manufacture of body fat scales, despite its own procedures requiring such validation. This indicates a lack of adherence to established quality system requirements for medical device manufacturing.