# China NMPA Inspection - Wendeng City Orthopedic Technology Development Co., Ltd., Shandong Province - May 27, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/wendeng-city-orthopedic-technology-development-co-ltd-shandong-province/d4934fa4-6bf6-47af-bdc2-c23bbef103a3/
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> China NMPA unannounced inspection for Wendeng City Orthopedic Technology Development Co., Ltd., Shandong Province published May 27, 2016. An unannounced inspection conducted by the Shandong Provincial Food and Drug Administration, with its report published on May 27, 2016, revealed signi

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection of Shandong Wendeng Orthopedic Technology Development Co., Ltd.
- Company Name: Wendeng City Orthopedic Technology Development Co., Ltd., Shandong Province
- Publication Date: 2016-05-27
- Product Type: devices
- Summary: An unannounced inspection conducted by the Shandong Provincial Food and Drug Administration, with its report published on May 27, 2016, revealed significant non-compliance at Shandong Wendeng Zheng Gu Technology Development Co., Ltd. The inspection determined that the company's operational practices and quality controls did not conform to the stringent requirements stipulated by the Good Manufacturing Practice for Medical Devices. This indicated fundamental deficiencies within their established quality management system, which is crucial for ensuring the safety, efficacy, and quality of medical products.

As a direct consequence of these findings, the regulatory authority issued a clear directive to Shandong Wendeng Zheng Gu Technology Development Co., Ltd. The company has been ordered to immediately cease all production activities without delay. Furthermore, they are mandated to initiate a comprehensive rectification process to address all identified violations, correct the underlying system deficiencies, and re-establish full adherence to the regulatory framework governing medical device manufacturing. This enforcement action by the Chinese regulatory body underscores the importance of maintaining robust quality systems within the medical device sector to safeguard public health.

Company: https://www.globalkeysolutions.net/companies/wendeng-city-orthopedic-technology-development-co-ltd-shandong-province/06ee1238-09e1-42bf-b973-c67b893ba193/