# FDA 483 - Advanced Medical Design Co., Ltd. - January 19, 2023

Source: https://www.globalkeysolutions.net/records/483/advanced-medical-design-co-ltd/a7592066-dc6a-4cf4-b9e2-b7b9f40de5b0

> FDA 483 for Advanced Medical Design Co., Ltd. on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Medical Design Co., Ltd.
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Advanced Medical Design Co., Ltd. in New Taipei City, Taiwan, a medical device manufacturer, was inspected and cited for significant quality system deficiencies. Observations included inadequate procedures for evaluating purchased products and services, failure to register a contract manufacturer with the FDA, and systemic issues with complaint handling and investigation. Additionally, the firm failed to submit a Medical Device Report (MDR) within the required 30-day timeframe for a serious injury event.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/advanced-medical-design-co-ltd/b4b4af21-7d79-466e-b84c-0cda5dc27a1d

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