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

Source: https://www.keypedia.com/records/483/xinyu-electronic-co-ltd/258a807d-542a-4f35-b2a3-0934116f19c2

> FDA 483 for Xinyu Electronic Co Ltd on March 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xinyu Electronic Co Ltd
- Inspection Date: 2019-03-07
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

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