FDA 483 - Regent Electron (Suzhou) Co., Ltd. - August 15, 2024

Regent Electron (Suzhou) Co., Ltd., a medical device manufacturer, was inspected regarding its watch-style wearable Echocardiograph and Oximeter devices. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate control of non-conforming products, incomplete corrective and preventive action procedures, and poor environmental controls in manufacturing areas. Additionally, issues were noted with record retention, labeling documentation, and finished device acceptance procedures.