# China NMPA Inspection - Nanchang Medical Equipment Co., Ltd. - October 11, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/nanchang-medical-equipment-co-ltd/7940db24-6975-4d20-90cd-fa860cbfb613/
Source feed: China

> China NMPA unannounced inspection for Nanchang Medical Equipment Co., Ltd. published October 11, 2018. An unannounced inspection of Nanchang Weicai Medical Device Co., Ltd., conducted from September 6-7, 2018, revealed significant non-compliance with th

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Nanchang Medical Equipment Co., Ltd.
- Company Name: Nanchang Medical Equipment Co., Ltd.
- Publication Date: 2018-10-11
- Product Type: Device
- Summary: An unannounced inspection of Nanchang Weicai Medical Device Co., Ltd., conducted from September 6-7, 2018, revealed significant non-compliance with the Good Manufacturing Practice for Medical Devices and its Appendix for Sterile Medical Devices. The inspection identified five serious defects and eight general deficiencies, primarily impacting the production of Disposable Sterile Vaginal Speculums. Key serious violations included a lack of traceability for raw material batch numbers (polypropylene, polystyrene), absence of comprehensive production records across various manufacturing stages, and critically, incomplete and inaccurate ethylene oxide sterilization records missing vital parameters and operator signatures. Furthermore, the company used an inconsistent sterility test method, failed to operate the air purification system in a clean injection molding area (showing zero differential pressure), and had validation reports with erroneous dates for sterilization parameters. General deficiencies highlighted poor warehouse organization, inadequate pest control, incorrect equipment status labeling, and a lack of calibration validity periods for critical instruments. Environmental monitoring records were incomplete or absent, and cleanroom differential pressure monitoring was insufficient. In response, the company was ordered to immediately suspend all production for rectification. They are required to assess product safety risks, initiate product recalls if necessary, and address all identified deficiencies. Production can only resume after all rectifications are complete and approved through a follow-up inspection by the Jiangxi Provincial Food and Drug Administration. The Provincial Administration will publish the company's rectification progress and regulatory actions.

Company: https://www.globalkeysolutions.net/companies/nanchang-medical-equipment-co-ltd/7015714e-5b20-4940-b684-b1e40cb5f2ff/