# FDA 483 - Global Fabtech Wheelchair (Shanghai) Co., Ltd. - April 04, 2019

Source: https://www.globalkeysolutions.net/records/483/global-fabtech-wheelchair-shanghai-co-ltd/7e0de9ca-63b0-4715-8c56-976fcd21fbdc

> FDA 483 for Global Fabtech Wheelchair (Shanghai) Co., Ltd. on April 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Fabtech Wheelchair (Shanghai) Co., Ltd.
- Inspection Date: 2019-04-04
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Global Fabtech Wheelchair (Shanghai) Co. Ltd., a medical device manufacturer, identified two significant issues. The firm failed to adequately document process validation activities for automated welding machines used in scooter frame production. Additionally, procedures for the routine calibration of torque wrenches were not consistently followed, leading to incomplete test results.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/global-fabtech-wheelchair-shanghai-co-ltd/c27c52fb-6685-4dcc-81ca-ef4aac9d7e74

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