# China NMPA Inspection - Liuzhou Ruikang Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/liuzhou-ruikang-medical-equipment-co-ltd/c6bcb2e3-6900-47aa-88cf-62ecfb203742/
Source feed: China

> China NMPA unannounced inspection for Liuzhou Ruikang Medical Equipment Co., Ltd. published January 09, 2018. An unannounced inspection conducted by the FDA NMPA on November 22-23, 2017, at Liuzhou Ruikang Medical Device Co., Ltd., revealed significant non-com

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Liuzhou Ruikang Medical Device Co., Ltd.
- Company Name: Liuzhou Ruikang Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection conducted by the FDA NMPA on November 22-23, 2017, at Liuzhou Ruikang Medical Device Co., Ltd., revealed significant non-compliance with the Good Manufacturing Practice for Medical Devices. The inspection identified a total of 18 deficiencies, comprising 5 critical and 13 general defects, indicating systemic breakdowns in the company's quality management system.Key violations included failures in the incoming goods inspection process, with undocumented products found and inventory discrepancies. Critical personnel issues were noted, such as the quality manager's unfamiliarity with medical device regulations and adverse event reporting, and the use of non-employee personnel for crucial outbound and verification tasks without proper contracts or appointments. Furthermore, the company failed to assess personnel training effectiveness and its computer information management system lacked essential functions for verifying supplier and purchaser legality.Additional deficiencies encompassed inadequate documentation in cooperative and distribution agreements, absence of required purchase records, and incomplete sales and acceptance records lacking critical details like manufacturer information, storage conditions, and proper product identification. Non-compliant storage conditions for medical devices and a lack of regular inventory quality checks were also observed. The company is required to implement comprehensive corrective actions to address these fundamental deficiencies and ensure full adherence to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/liuzhou-ruikang-medical-equipment-co-ltd/58672b51-960a-47d2-a4fb-7e3512306624/