# FDA 483 - Shanghai Kindly Enterprise Development Group Co., Ltd - July 19, 2011

Source: https://www.globalkeysolutions.net/records/483/shanghai-kindly-enterprise-development-group-co-ltd/dcc4426c-eb30-40c9-9de3-6d6bf5ad811a

> FDA 483 for Shanghai Kindly Enterprise Development Group Co., Ltd on July 19, 2011. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai Kindly Enterprise Development Group Co., Ltd
- Inspection Date: 2011-07-19
- Product Type: device
- Office Name: Division of Advertising & Promotion 
- Summary: Shanghai Kindly Enterprise Development Group Co., Ltd. in Shanghai, China, a medical device manufacturer, was inspected by the FDA from July 18-19, 2011. The inspection revealed issues with design verification documentation, inadequate equipment calibration schedules, and improper document approval procedures. These observations indicate deficiencies in the firm's quality system for medical device manufacturing.

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## Related Officers

- [James W. Leonette](https://www.globalkeysolutions.net/people/james-w-leonette/9507ec02-14fc-4172-974f-c7c6518cf9ad)

Company: https://www.globalkeysolutions.net/companies/shanghai-kindly-enterprise-development-group-co-ltd/83f2b7f2-55f6-4fba-909f-dd460b096668

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0