# FDA 483 - Wu's Tech Co., Ltd. - August 30, 2018

Source: https://www.globalkeysolutions.net/records/483/wus-tech-co-ltd/bd1987e7-836d-48a9-953e-c4162764a23c

> FDA 483 for Wu's Tech Co., Ltd. on August 30, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wu's Tech Co., Ltd.
- Inspection Date: 2018-08-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wu's Tech Co., Ltd. in Hsin-Chu, Taiwan, was inspected by the FDA, revealing issues with their manufacturing processes for medical devices. The inspection found that procedures for finished device acceptance were not adequately established, with discrepancies in specifications and undocumented verifications. Additionally, document control procedures were insufficient, leading to manufacturing forms not being properly safeguarded.

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.globalkeysolutions.net/companies/wus-tech-co-ltd/fa1f63ed-9f31-47cc-b3b9-5f25632b2efb

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