# FDA 483 - Shanghai ISO Medical Products Co., Ltd. - November 16, 2023

Source: https://www.globalkeysolutions.net/records/483/shanghai-iso-medical-products-co-ltd/7444cf47-d8ba-41e8-82d2-1d9367e8136a

> FDA 483 for Shanghai ISO Medical Products Co., Ltd. on November 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanghai ISO Medical Products Co., Ltd.
- Inspection Date: 2023-11-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Shanghai ISO Medical Products Co., Ltd. in Shanghai, China, a medical device manufacturer, identified two observations. The firm was cited for failing to ensure medical device labels bear a Unique Device Identifier (UDI) as required. Additionally, the device history records did not adequately demonstrate that devices were manufactured according to the device master record, specifically regarding the packaging process.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/shanghai-iso-medical-products-co-ltd/fdd1ed08-5329-4ea8-b0f5-8f5e5461c79a

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