# China NMPA Inspection - Nanjing MicroPort Medical Technology Co., Ltd. - June 28, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/nanjing-microport-medical-technology-co-ltd/b69a27b6-a6fd-44f4-a5dc-f11ac29a560d/
Source feed: China

> China NMPA unannounced inspection for Nanjing MicroPort Medical Technology Co., Ltd. published June 28, 2018. Nanjing MicroPort Medical Technology Co., Ltd. was subject to an unannounced compliance inspection by the NMPA from June 5 to June 7, 2018, concerning

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Nanjing MicroPort Medical Technology Co., Ltd.
- Company Name: Nanjing MicroPort Medical Technology Co., Ltd.
- Publication Date: 2018-06-28
- Product Type: Device
- Summary: Nanjing MicroPort Medical Technology Co., Ltd. was subject to an unannounced compliance inspection by the NMPA from June 5 to June 7, 2018, concerning its Covered Biliary Stent. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, revealed several significant deviations from quality system requirements.

Key findings included deficiencies in material control, such as raw materials stored in inspection-pending areas despite passing checks, and discrepancies between physical and documented material quantities. Procedural issues were noted, with a revised procurement control document becoming effective before its official approval. The company also lacked complete design and development input and review files for its stents, and the quality standard for nickel-titanium alloy wire was incomplete compared to national requirements. Environmental monitoring records showed inconsistencies, and material recipients did not consistently sign disinfection records. Facility issues included the absence of a dedicated final cleaning room for tools in the stent production workshop, and a lack of verification for residual components in instant adhesives. Additionally, improper storage of chemicals and the failure to test long-stored semi-finished nickel-titanium alloy stents were identified.

Nanjing MicroPort is mandated to promptly rectify all identified issues, conduct a comprehensive assessment of product safety risks, and recall any products deemed to pose safety hazards. The Jiangsu Provincial Food and Drug Administration will oversee the rectification process, conduct necessary follow-up inspections, and report the company's progress to the National Medical Products Administration.

Company: https://www.globalkeysolutions.net/companies/nanjing-microport-medical-technology-co-ltd/0b98e7f8-a2e6-4741-a8f2-849df543dd29/