# China NMPA Inspection - Zhejiang Kindly Medical Devices Co., Ltd. - June 23, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/zhejiang-kindly-medical-devices-co-ltd/540fcb75-6c8e-4319-9737-7ec84536daeb/
Source feed: China

> China NMPA unannounced inspection for Zhejiang Kindly Medical Devices Co., Ltd. published June 23, 2017. An unannounced inspection by the State Food and Drug Administration (SFDA) in May 2017, conducted under the "Regulations on Unannounced Inspections of

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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 Zhejiang Yiyi Medical Device Co., Ltd. and Zhejiang Xinna Medical Device Technology Co., Ltd. to Rectify Problems Found During Unannounced Inspections
- Company Name: Zhejiang Kindly Medical Devices Co., Ltd.
- Publication Date: 2017-06-23
- Product Type: Device
- Summary: An unannounced inspection by the State Food and Drug Administration (SFDA) in May 2017, conducted under the "Regulations on Unannounced Inspections of Drugs and Medical Devices," identified compliance issues at two Zhejiang-based medical device manufacturers. Zhejiang Yiyi Medical Device Co., Ltd. was inspected from May 22-23, 2017, concerning its single-use sterile insulin syringes. Identified deficiencies included inadequate documentation for measuring tools and revised management documents, unauthorized alterations in production records without proper identification, illegible analytical records, and missing performance confirmation for calibrated equipment. Yiyi must rectify these issues promptly, potentially face follow-up inspections, and recall any products with safety risks in accordance with "Regulations on the Recall Management of Medical Devices." Rectification status must be reported to the SFDA. Zhejiang Xinna Medical Device Technology Co., Ltd. was found to have ceased production. The company is required to report its production resumption status and submit a written plan for verification by the provincial bureau before restarting operations, with this information also relayed to the SFDA. The Zhejiang Provincial Food and Drug Administration is mandated to enhance daily supervision, rigorously enforce "Good Manufacturing Practice for Medical Devices" and its "Appendix: Sterile Medical Devices," and increase oversight of companies with identified issues to ensure product safety and effectiveness.

Company: https://www.globalkeysolutions.net/companies/zhejiang-kindly-medical-devices-co-ltd/01df2ff2-a84a-4e38-bab0-7054a3935101/