# China NMPA Inspection - Qinhuangdao Ruike Medical Device Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/qinhuangdao-ruike-medical-device-co-ltd/aadaf9aa-94d6-478a-8418-8cd281c7fbfc/
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> China NMPA unannounced inspection for Qinhuangdao Ruike Medical Device Co., Ltd. published January 09, 2018. An unannounced inspection of Qinhuangdao Ruike Medical Device Co., Ltd. was conducted on November 22-23, 2017, to assess compliance with medical devic

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Qinhuangdao Ruike Medical Device Co., Ltd.
- Company Name: Qinhuangdao Ruike Medical Device Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection of Qinhuangdao Ruike Medical Device Co., Ltd. was conducted on November 22-23, 2017, to assess compliance with medical device regulations. Based on the *Good Manufacturing Practice for Medical Devices*, the inspection revealed nine defects, comprising two critical and seven general issues, indicating significant lapses in the company's quality management system.Key violations included the failure to conduct regular quality management system inspections and maintain continuous improvement records. The company also lacked proper documentation for the disposal of scrapped medical devices and exhibited deficiencies in purchase contracts, such as missing product registration numbers and quality responsibility stipulations. Inventory management was also problematic, with incomplete shipment receipts, absent production dates in incoming inspection records, and a general failure to document the handling of non-conforming products. Furthermore, storage conditions were found to be inadequate, with medical devices not protected from light, co-mingled with non-medical items, and improperly stored directly on the ground. The company also failed to establish comprehensive after-sales service procedures and an adequate adverse reaction reporting system, which lacked defined responsibilities and monitoring reports.In response to these findings, the Hebei Provincial Food and Drug Administration is required to mandate that Qinhuangdao Ruike Medical Device Co., Ltd. rectify all identified problems within a specified timeframe. Follow-up inspections will be conducted, and the relevant information will be reported to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/qinhuangdao-ruike-medical-device-co-ltd/b25ebe71-9f4a-4fa3-a101-6a216391fbc7/