# China NMPA Inspection - Jiangsu Qianjing Medical Device Co., Ltd. - June 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/jiangsu-qianjing-medical-device-co-ltd/bd576df1-3301-4321-88db-5af918623b93/
Source feed: China

> China NMPA unannounced inspection for Jiangsu Qianjing Medical Device Co., Ltd. published June 28, 2018. An unannounced inspection of Jiangsu Qianjing Medical Device Co., Ltd., conducted by the NMPA from June 7-8, 2018, identified 17 general deficiencies 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Jiangsu Qianjing Medical Device Co., Ltd.
- Company Name: Jiangsu Qianjing Medical Device Co., Ltd.
- Publication Date: 2018-06-28
- Product Type: Device
- Summary: An unannounced inspection of Jiangsu Qianjing Medical Device Co., Ltd., conducted by the NMPA from June 7-8, 2018, identified 17 general deficiencies concerning the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*. The inspection focused on their Disposable Arc-Shaped Cutting Anastomosis Device.

Key issues included widespread problems with labeling and identification, such as unlabeled raw material boxes, cleaning containers, and production equipment. Significant documentation and procedural control failures were noted, including inconsistencies in document formatting, unrevised process flowcharts after changes, and outdated inspection procedures despite updated product technical requirements. Supplier management practices were inadequate, and there were deficiencies in validation processes for ultrasonic cleaning and water purification systems.

Further violations encompassed inaccurate and incomplete production records, poor label management, and issues with equipment status and environmental control for testing instruments. Critically, sample retention practices deviated from established regulations, and the company inadequately assessed the impact of non-conforming water quality on product safety. Deficiencies in disinfectant management documentation were also observed.

Jiangsu Qianjing Medical Device Co., Ltd. is required to fulfill its primary responsibility for product quality and safety, analyze the root causes of these deficiencies, assess associated safety risks, and implement necessary measures to control these risks effectively.

Company: https://www.globalkeysolutions.net/companies/jiangsu-qianjing-medical-device-co-ltd/137f0985-5947-4710-aa08-fc40148ceb49/