# China NMPA Inspection - Dalian JMS Medical Equipment Co., Ltd. - January 09, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/dalian-jms-medical-equipment-co-ltd/a0faa66a-7045-49a9-9bca-86eca9e6d1d5/
Source feed: China

> China NMPA unannounced inspection for Dalian JMS Medical Equipment Co., Ltd. published January 09, 2018. An unannounced inspection of Dalian JMS Medical Devices Co., Ltd. was conducted from November 22-23, 2017, focusing on compliance with Good Manufactur

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Dalian JMS Medical Equipment Co., Ltd.
- Company Name: Dalian JMS Medical Equipment Co., Ltd.
- Publication Date: 2018-01-09
- Product Type: Device
- Summary: An unannounced inspection of Dalian JMS Medical Devices Co., Ltd. was conducted from November 22-23, 2017, focusing on compliance with Good Manufacturing Practice for Medical Devices and the Regulations on the Supervision and Administration of Medical Devices. The inspection revealed five deficiencies, including one critical and four general issues.

Significant violations included the absence of a quality management self-inspection system within the company's official procedures. Furthermore, Dalian JMS Medical Devices failed to provide essential training documentation for 2017, encompassing plans, content, records, and assessments. The warehouse lacked a dedicated shipping area, a fundamental aspect of proper inventory management. Critical inventory discrepancies were identified, such as the computer system showing 403 units of a specific product while only 293 were physically present. Another instance revealed products recorded as received and in the 'Inspection Warehouse' were not found on-site. Lastly, outbound verification processes posed a risk, as delivery notes indicated company employees as shippers and verifiers, whereas the actual personnel were agents of an entrusted transportation company.

As a result, the Liaoning Provincial Food and Drug Administration is required to order Dalian JMS Medical Devices Co., Ltd. to rectify these issues within a defined period. Follow-up inspections will be conducted, and the findings reported to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/dalian-jms-medical-equipment-co-ltd/72ff1e05-9328-45c8-80c0-fe7f82683b99/