# China NMPA Inspection - Zibo Kangbei Medical Equipment Co., Ltd. - May 23, 2016

Source: https://www.globalkeysolutions.net/records/china_inspection/zibo-kangbei-medical-equipment-co-ltd/c52367e3-2e19-4f69-8cad-ee648ec215d7/
Source feed: China

> China NMPA unannounced inspection for Zibo Kangbei Medical Equipment Co., Ltd. published May 23, 2016. An unannounced inspection by the Shandong Provincial Food and Drug Administration, reported on May 23, 2016, identified significant non-compliance at 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Surprise inspection of Zibo Kangbei Medical Device Co., Ltd.
- Company Name: Zibo Kangbei Medical Equipment Co., Ltd.
- Publication Date: 2016-05-23
- Product Type: devices
- Summary: An unannounced inspection by the Shandong Provincial Food and Drug Administration, reported on May 23, 2016, identified significant non-compliance at Zibo Kangbei Medical Device Co., Ltd. The regulatory review revealed that the company's operational practices and overall quality management system did not align with the established national Good Manufacturing Practice for Medical Devices (GMP) framework. The inspection specifically noted multiple actions undertaken by Zibo Kangbei Medical Device Co., Ltd. that were inconsistent with the relevant manufacturing standards. These deficiencies indicated shortcomings within the company's quality control framework, which is crucial for ensuring the safety and effectiveness of medical devices. In response to these findings, the regulatory authority has issued a directive requiring Zibo Kangbei Medical Device Co., Ltd. to undertake prompt corrective actions. The company is mandated to rectify all identified deficiencies within a specified period, thereby bringing its manufacturing processes and quality management system into full adherence with the Good Manufacturing Practice for Medical Devices. This action emphasizes the regulator's commitment to maintaining stringent standards within the medical device industry for public health and safety.

Company: https://www.globalkeysolutions.net/companies/zibo-kangbei-medical-equipment-co-ltd/35f6310c-94bc-471b-99d9-e205f9e11ca5/