# China NMPA Inspection - Chifeng Jiuzhou Tongda Medical Equipment Co., Ltd. - October 30, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/chifeng-jiuzhou-tongda-medical-equipment-co-ltd/d8fcbeea-bd1d-4eec-ad88-123a89754ba6/
Source feed: China

> China NMPA unannounced inspection for Chifeng Jiuzhou Tongda Medical Equipment Co., Ltd. published October 30, 2018. An unannounced inspection of Chifeng Jiuzhou Tongda Medical Device Co., Ltd., a manufacturer of disposable infusion sets, occurred from October 16-17,

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Chifeng Jiuzhou Tongda Medical Device Co., Ltd.
- Company Name: Chifeng Jiuzhou Tongda Medical Equipment Co., Ltd.
- Publication Date: 2018-10-30
- Product Type: Device
- Summary: An unannounced inspection of Chifeng Jiuzhou Tongda Medical Device Co., Ltd., a manufacturer of disposable infusion sets, occurred from October 16-17, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices, revealed 17 deficiencies. Key issues included inadequate lighting in production workshops and improper storage and labeling of raw materials and non-conforming products. The company exhibited poor document control, with obsolete process tables in use and a failure to define control methods for all material categories. A significant change in the production process, specifically the discontinuation of washing steps, lacked proper review, verification, or confirmation records. Furthermore, defective products were found without disposal records, and effective preventive actions were not implemented following customer feedback on product quality. Internal audit documentation was incomplete. Critical environmental controls for sterile manufacturing were also violated, with humidity levels below requirements in clean areas and issues with differential pressure monitoring. Sterility testing documentation exhibited omissions, including missing test bases and reviewer signatures. The regulatory authority requires Chifeng Jiuzhou Tongda to rectify all identified problems within a specified period, assess product safety risks, recall any potentially unsafe products, and submit a comprehensive report of their rectification actions to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/chifeng-jiuzhou-tongda-medical-equipment-co-ltd/ddb19d4f-3b75-44d4-8c4d-b27aa3637649/