# FDA 483 - Inventys Power Design Center - April 08, 2019

Source: https://www.keypedia.com/records/483/inventys-power-design-center/e6d3cf29-2680-4ab9-b7ac-52999bdb9746

> FDA 483 for Inventys Power Design Center on April 08, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inventys Power Design Center
- Inspection Date: 2019-04-08
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Inventys Power Design Center, a Class II medical device manufacturer in Guangzhou City, China, revealed a significant issue with design verification documentation. The firm failed to properly document and file design verification results, specifically lacking raw data to support verification reports. This indicates a deficiency in their design history file management.

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/inventys-power-design-center/bc769cf9-9c9b-4457-8e16-21ac1fe0b2ee

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd