# FDA 483 - Wu's Tech (Vietnam) Co., Ltd. - August 02, 2018

Source: https://www.keypedia.com/records/483/wus-tech-vietnam-co-ltd/1d276e00-a86e-4eea-a5dc-9c8e0b29ac79

> FDA 483 for Wu's Tech (Vietnam) Co., Ltd. on August 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wu's Tech (Vietnam) Co., Ltd.
- Inspection Date: 2018-08-02
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wu's Tech (Vietnam) Co., Ltd. was inspected as a medical device manufacturer, revealing two significant issues. The firm failed to establish proper production procedures for the assembly of 4-Wheel Scooters and did not submit Medical Device Reports (MDRs) within 30 days for multiple serious injury complaints related to scooter tip-overs. These findings highlight critical deficiencies in quality system controls and post-market surveillance.

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## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/wus-tech-vietnam-co-ltd/08130980-9fef-4cc9-8988-7006a93dd91b

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