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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.