# China NMPA Inspection - Changchun Minjian Medical Device Co., Ltd. - December 13, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/changchun-minjian-medical-device-co-ltd/9aeccd20-f5b8-4585-b9b1-ebe8edc3d62a/
Source feed: China

> China NMPA unannounced inspection for Changchun Minjian Medical Device Co., Ltd. published December 13, 2018. An unannounced inspection of Changchun Minjian Medical Device Co., Ltd. was conducted by regulatory authorities from November 7-9, 2018. The inspectio

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Changchun Minjian Medical Device Co., Ltd.
- Company Name: Changchun Minjian Medical Device Co., Ltd.
- Publication Date: 2018-12-13
- Product Type: Device
- Summary: An unannounced inspection of Changchun Minjian Medical Device Co., Ltd. was conducted by regulatory authorities from November 7-9, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its appendix for sterile medical devices, revealed multiple deficiencies. Key violations included significant issues with facility control, such as a lack of rodent control, damaged and obstructed cleanroom ventilation, exposed electrical wiring, and unsealed doors. Personnel hygiene was also a concern, with employees seen applying makeup in cleanrooms and failing to adhere to proper gowning and handwashing protocols. Furthermore, the company exhibited critical failures in documentation and record-keeping, including the absence of approved testing procedures, incomplete batch production records lacking crucial equipment details or showing inconsistent parameters, and no records for design changes or material disinfection. Equipment failures, such as a malfunctioning UV lamp for material transfer, were also noted. The Jilin Provincial Drug Administration has mandated that Changchun Minjian Medical Device Co., Ltd. rectify these issues within a specified timeframe. The company must assess product safety risks, recall any hazardous products, and report their corrective actions to the National Medical Products Administration. Follow-up inspections may also be conducted to ensure compliance.

Company: https://www.globalkeysolutions.net/companies/changchun-minjian-medical-device-co-ltd/63f06c20-03a1-47cc-bc11-0025a6bc73b3/