# China NMPA Inspection - Shaanxi Zhengyuan Technology Development Co., Ltd. - September 29, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/shaanxi-zhengyuan-technology-development-co-ltd/34eb899b-acef-4dc0-a5fe-bd14b041b33b/
Source feed: China

> China NMPA unannounced inspection for Shaanxi Zhengyuan Technology Development Co., Ltd. published September 29, 2016. An unannounced inspection conducted by the Shaanxi Provincial Food and Drug Administration identified significant deficiencies at Shaanxi Zhengyuan Te

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Shaanxi Zhengyuan Technology Development Co., Ltd.
- Company Name: Shaanxi Zhengyuan Technology Development Co., Ltd.
- Publication Date: 2016-09-29
- Product Type: Device
- Summary: An unannounced inspection conducted by the Shaanxi Provincial Food and Drug Administration identified significant deficiencies at Shaanxi Zhengyuan Technology Development Co., Ltd. The inspection report, published on September 29, 2016, revealed that the company's operations did not comply with the stringent requirements of the Good Manufacturing Practice for Medical Devices. Specifically, the company's quality management system was found to have multiple shortcomings that did not meet the established regulatory standards. As a result of these findings, Shaanxi Zhengyuan Technology Development Co., Ltd. has been formally ordered to rectify all identified deficiencies within a specified timeframe. This directive aims to ensure the company's full adherence to the regulatory framework governing medical device manufacturing, thereby safeguarding product quality and patient safety. The National Medical Products Administration (NMPA) hosts the official report, reinforcing the regulatory oversight in the industry.

Company: https://www.globalkeysolutions.net/companies/shaanxi-zhengyuan-technology-development-co-ltd/fce77f8f-1604-42b9-ac7a-69ec7325732b/