# FDA 483 - Wu's Tech (Vietnam) Co., Ltd. - September 22, 2022

Source: https://www.keypedia.com/records/483/wus-tech-vietnam-co-ltd/c7459b71-df0f-4626-a88c-1820d87adb27

> FDA 483 for Wu's Tech (Vietnam) Co., Ltd. on September 22, 2022. 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: 2022-09-22
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wu's Tech (Vietnam) Co., Ltd., a medical device manufacturer in Thu Dau Mot City, Binh Duong Vietnam, received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, medical device reporting (MDR), and labeling control. These issues indicate a lack of robust quality management practices for their medical devices.

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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