# China NMPA Inspection - Wugang Ruifeng Medical Technology Co., Ltd. - July 06, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/wugang-ruifeng-medical-technology-co-ltd/90bc97f7-b40a-48e2-b1d9-de90dd2bda48/
Source feed: China

> China NMPA unannounced inspection for Wugang Ruifeng Medical Technology Co., Ltd. published July 06, 2016. Wugang Ruifeng Medical Technology Co., Ltd. declared a production cessation on December 5, 2014, attributing this decision to significant staff instab

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Wugang Ruifeng Medical Technology Co., Ltd.
- Company Name: Wugang Ruifeng Medical Technology Co., Ltd.
- Publication Date: 2016-07-06
- Product Type: Device
- Summary: Wugang Ruifeng Medical Technology Co., Ltd. declared a production cessation on December 5, 2014, attributing this decision to significant staff instability. Key personnel, particularly within the crucial quality management and inspection departments, had departed, rendering the company unable to maintain its operational integrity and meet regulatory standards for medical device manufacturing. An official on-site verification subsequently confirmed the company's inactive production status. Under the relevant regulatory framework, specifically overseen by the Henan Provincial Food and Drug Administration, the company faces clear directives for re-establishing compliance. Before any manufacturing activities can resume, Wugang Ruifeng Medical Technology Co., Ltd. is required to submit a detailed written report to the provincial authority. This report must demonstrate that the issues leading to the production halt have been adequately addressed, including the re-establishment of qualified personnel and robust quality systems. Production can only recommence after the Henan Provincial Food and Drug Administration conducts a thorough review and verifies that the company fully meets all stipulated requirements, ensuring patient safety and product quality are not compromised by inadequate staffing or operational deficiencies. This proactive regulatory oversight aims to prevent substandard products from entering the market.

Company: https://www.globalkeysolutions.net/companies/wugang-ruifeng-medical-technology-co-ltd/1689f44b-c615-4012-9701-87f49cee19d1/