Kun “James” Hu
CEO
Contec Medical Systems Co., Ltd.
No. 112 Qinhuang West Street
Economic and Technical Development Zone
Qinhuangdao Shi
Hebei Sheng , 066004
ChinaFEI 3006979678Issued Oct 2, 2025Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3006979678.
Violations5
Issue DateOct 2, 2025
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Contec Medical Systems Co., Ltd.
Location
Kun “James” Hu
CEO
Contec Medical Systems Co., Ltd.
No. 112 Qinhuang West Street
Economic and Technical Development Zone
Qinhuangdao Shi
Hebei Sheng , 066004
China
FEI Number
3006979678
Country
China
Issue Date
October 02, 2025
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Contec Medical Systems Co., Ltd., a Chinese manufacturer of patient monitors, ultrasound diagnostic systems, pulse oximeters, and fetal dopplers, was found to have produced adulterated devices that failed to comply with FDA's Quality System Regulation (21 CFR Part 820). The inspection revealed critical deficiencies in the company's corrective and preventive action (CAPA) procedures, including inadequate investigation of nonconformities, undocumented corrective actions, and incomplete preventive action documentation. The FDA issued this warning letter on October 2, 2025, following a June 2025 inspection and the company's July 2025 response to the initial Form FDA 483 observations.
Contec Medical Systems Co., Ltd. FDA Warning Letter, October 2, 2025
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