# China NMPA Inspection - Weifang Jianbu Medical Equipment Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/weifang-jianbu-medical-equipment-co-ltd/30889429-c850-4797-bd23-428cef2b368a/
Source feed: China

> China NMPA unannounced inspection for Weifang Jianbu Medical Equipment Co., Ltd. published January 10, 2018. An unannounced inspection of Weifang Jianbu Medical Device Co., Ltd. was conducted from November 21st to November 23rd, 2017, to assess compliance wit

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Weifang Jianbu Medical Device Co., Ltd.
- Company Name: Weifang Jianbu Medical Equipment Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: An unannounced inspection of Weifang Jianbu Medical Device Co., Ltd. was conducted from November 21st to November 23rd, 2017, to assess compliance with Good Manufacturing Practice for Medical Devices. The inspection revealed three defects, comprising one critical and two general issues, indicating significant deficiencies in the company’s quality management system. A primary critical finding was the absence of an adequate self-inspection system for quality management, despite the company holding a Class III medical device business license. The company also failed to submit required annual self-inspection reports to the municipal food and drug administration. Furthermore, the quality manager demonstrated a lack of awareness regarding mandatory supplier auditing procedures prior to procurement, indicating a fundamental gap in supply chain control. Lastly, the company failed to implement its documented "Training Plan," specifically lacking records for essential new employee and quality training that was stipulated to occur five days before new hires commenced work. Based on these findings, the Shandong Provincial Food and Drug Administration has mandated that Weifang Jianbu Medical Device Co., Ltd. promptly rectify all identified deficiencies within a defined timeframe, as per the "Regulations on the Supervision and Administration of Medical Devices." Follow-up inspections will be conducted, and upon successful remediation, the information must be reported to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/weifang-jianbu-medical-equipment-co-ltd/6e743846-63da-4cad-a2dc-0586d77e9aca/