Regent Electron (Suzhou) Co., Ltd. – FDA 483, Aug 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.
ID · e2634904-b194-4cf9-a991-aa5dd1897538
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