# China NMPA Inspection - Yangzhou Huanyu Medical Equipment Co., Ltd. - July 13, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/yangzhou-huanyu-medical-equipment-co-ltd/27bce638-8e29-4a79-94b5-597c78f60046/
Source feed: China

> China NMPA unannounced inspection for Yangzhou Huanyu Medical Equipment Co., Ltd. published July 13, 2016. An important report, published on July 13, 2016, by the Jiangsu Provincial Food and Drug Administration, details the outcome of an unannounced inspect

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Yangzhou Huanyu Medical Equipment Co., Ltd.
- Company Name: Yangzhou Huanyu Medical Equipment Co., Ltd.
- Publication Date: 2016-07-13
- Product Type: devices
- Summary: An important report, published on July 13, 2016, by the Jiangsu Provincial Food and Drug Administration, details the outcome of an unannounced inspection conducted at Yangzhou Huanyu Medical Device Co., Ltd. The purpose of this inspection was to assess the company's adherence to stringent regulatory standards for medical device manufacturing. The inspection revealed critical non-compliances, specifically identifying that the company's operational practices did not meet the requirements outlined in the Good Manufacturing Practice for Medical Devices. Furthermore, significant deficiencies were observed within its overall quality management system, indicating systemic issues in maintaining proper manufacturing controls. In response to these serious findings, the regulatory authority has issued a directive requiring Yangzhou Huanyu Medical Device Co., Ltd. to immediately cease all production activities. The company is further mandated to undertake prompt and comprehensive rectification efforts to address all identified shortcomings and bring its operations into full compliance with the established regulatory framework. This decisive action highlights the provincial administration's commitment to upholding the integrity and safety standards within the medical device industry, ensuring that only compliant products reach the market.

Company: https://www.globalkeysolutions.net/companies/yangzhou-huanyu-medical-equipment-co-ltd/0ee953ee-5cbf-4c19-a8d9-d2a3b81a6c19/