# FDA 483 - Global Medical Production Co Ltd - July 30, 2021

Source: https://www.globalkeysolutions.net/records/483/global-medical-production-co-ltd/9e7bfe84-185d-4914-8155-f51998858861

> FDA 483 for Global Medical Production Co Ltd on July 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Medical Production Co Ltd
- Inspection Date: 2021-07-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Global Medical Production Co., Ltd. in Jiaxing, China, revealed numerous significant deficiencies in their quality system for medical devices exported to the US market. The firm lacked essential procedures for complaint handling, medical device reporting, design control, and device master records. Additionally, issues were identified with process validation, product identification, nonconforming product control, equipment maintenance, device history records, and personnel's understanding of US FDA regulations.

## Related Officers

- [Felix J. Marrero](https://www.globalkeysolutions.net/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.globalkeysolutions.net/companies/global-medical-production-co-ltd/60ebf2bd-a420-46f7-9ac8-7bf7b4c5cf66

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