# China NMPA Inspection - Shenzhen Ruixio Medical Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/shenzhen-ruixio-medical-co-ltd/8633c031-52fa-4355-aefa-b09863e8dbe7/
Source feed: China

> China NMPA unannounced inspection for Shenzhen Ruixio Medical Co., Ltd. published January 10, 2018. An unannounced inspection of Shenzhen Ruixio Medical Co., Ltd. was conducted from November 21st to November 23rd, 2017, focusing on compliance with Go

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Shenzhen Ruixio Medical Co., Ltd.
- Company Name: Shenzhen Ruixio Medical Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: An unannounced inspection of Shenzhen Ruixio Medical Co., Ltd. was conducted from November 21st to November 23rd, 2017, focusing on compliance with Good Manufacturing Practice for Medical Devices. The inspection identified five defects, comprising one critical and four general issues.

The critical violation involved severe discrepancies in the inventory management system for Pioneer implants. Records from customs declarations, computer purchase orders, computer inventory, and actual warehouse stock did not match. Additionally, the company was cited for selling Pioneer implants directly to individuals, deviating from regulated distribution channels. 

General issues included a lack of documented training for employees on regulations, standards, and the quality management system. Furthermore, purchase contracts with suppliers did not clearly define after-sales service responsibilities, and the warehouse failed to maintain proper temperature and humidity records. 

Based on these findings, the Guangdong Provincial Food and Drug Administration is required to mandate that Shenzhen Ruixio Medical Co., Ltd. rectify all identified non-conformities within a specified period. Follow-up inspections will be conducted, and successful rectification must be reported to the Medical Device Supervision Department of the State Administration for Market Regulation, in accordance with the Regulations on the Supervision and Administration of Medical Devices.

Company: https://www.globalkeysolutions.net/companies/shenzhen-ruixio-medical-co-ltd/6037624f-99aa-4f42-90f1-21bbffb09f23/