# FDA 483 - Contec Medical Systems Co., Ltd. - June 12, 2025

Source: https://www.keypedia.com/records/483/contec-medical-systems-co-ltd/ef728b05-2d12-4a8b-89eb-bd5930dd0698

> FDA 483 for Contec Medical Systems Co., Ltd. on June 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contec Medical Systems Co., Ltd.
- Inspection Date: 2025-06-12
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Contec Medical Systems Co., Ltd. in Qinhuangdao, China, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for corrective and preventive actions, design validation (including software), and complaint handling. Additionally, the inspection found issues with record accessibility and an organizational structure where personnel lacked product familiarity and struggled to locate quality documentation.

## Related Documents

- [WARNING_LETTER - 2025-06-12](https://www.keypedia.com/records/warning_letter/contec-medical-systems-co-ltd/049b73d6-e1f7-4438-b110-cef6cf0c6629)

## Related Officers

- [Jamie P. Webb](https://www.keypedia.com/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.keypedia.com/companies/contec-medical-systems-co-ltd/04451b39-0e00-42e6-9403-9595a822db69

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8