# China NMPA Inspection - Shenzhen Yixinda Medical New Technology Co., Ltd. - July 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/shenzhen-yixinda-medical-new-technology-co-ltd/ee52dcf1-2fbc-4c6f-884a-6170a95e9fdb/
Source feed: China

> China NMPA unannounced inspection for Shenzhen Yixinda Medical New Technology Co., Ltd. published July 07, 2017. An unannounced inspection by the State Food and Drug Administration (NMPA) from June 8-9, 2017, revealed significant deficiencies at Shenzhen Yixinda 

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notice from the General Office of the State Administration of Radio and Television on Urging Shenzhen Yixinda Medical New Technology Co., Ltd. to Rectify Problems Found During Flight Inspections
- Company Name: Shenzhen Yixinda Medical New Technology Co., Ltd.
- Publication Date: 2017-07-07
- Product Type: Device
- Summary: An unannounced inspection by the State Food and Drug Administration (NMPA) from June 8-9, 2017, revealed significant deficiencies at Shenzhen Yixinda Medical New Technology Co., Ltd., a manufacturer of disposable infusion pumps. The inspection, conducted under the "Good Manufacturing Practice for Medical Devices" and its "Appendix for Sterile Medical Devices," identified ten general defects impacting product quality and safety.

Key issues included a lack of explicit authorization for quality management roles in the company's manual, improper storage of materials such as unlabeled test granules and expired reagents mixed with approved products, and the failure to identify critical manufacturing processes, specifically the silicone tubing matching that determines flow accuracy. Additionally, supplier evaluation was found to be inadequate; an overseas filter membrane supplier lacked documented proof of a compliant production environment, and insufficient biocompatibility data was provided for PVC granules, with the company failing to adequately assess risks related to raw material quality fluctuations for a component in indirect contact with the central circulatory system.

Shenzhen Yixinda Medical New Technology Co., Ltd. is required to promptly rectify these issues, with potential follow-up inspections to assess safety risks and initiate product recalls if necessary. The company must report its rectification progress to the NMPA. Furthermore, the Guangdong Provincial Food and Drug Administration is instructed to strengthen its daily supervision of the company to ensure strict adherence to manufacturing practices and maintain medical device safety and effectiveness.

Company: https://www.globalkeysolutions.net/companies/shenzhen-yixinda-medical-new-technology-co-ltd/e904cf24-50b4-405a-b113-f889f986429f/