# China NMPA Inspection - Chongqing Hengsheng Antuo Medical Equipment Co., Ltd. - January 10, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/chongqing-hengsheng-antuo-medical-equipment-co-ltd/d1898870-dea7-4583-be97-54f23ec403a5/
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> China NMPA unannounced inspection for Chongqing Hengsheng Antuo Medical Equipment Co., Ltd. published January 10, 2018. An unannounced inspection of Chongqing Hengsheng Antuo Medical Device Co., Ltd. was conducted from November 20th to November 21st, 2017. The inspectio

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Chongqing Hengsheng Antuo Medical Device Co., Ltd.
- Company Name: Chongqing Hengsheng Antuo Medical Equipment Co., Ltd.
- Publication Date: 2018-01-10
- Product Type: Device
- Summary: An unannounced inspection of Chongqing Hengsheng Antuo Medical Device Co., Ltd. was conducted from November 20th to November 21st, 2017. The inspection, guided by the *Good Manufacturing Practice for Medical Devices*, revealed six deficiencies, comprising one critical and five general defects. The critical finding pertained to the absence of stipulated processes for computer information system management, including the entry of entrusted storage and transportation information and system verification prior to use. General deficiencies encompassed the failure to provide required review forms for entrusted companies and products, an unfilled quality management position for in vitro diagnostic reagents, and missing health examination certificates for three personnel, including the warehouse manager. Furthermore, temperature and humidity monitoring facilities across all warehouses lacked regular calibration. Inconsistencies were identified in cold storage temperature verification reports, and the company's refrigerated truck operating procedures contradicted verification recommendations regarding door-opening durations. Consequently, the Chongqing Municipal Food and Drug Administration is mandated to order the company to rectify these issues within a specified period, conduct follow-up inspections, and report the rectification status to the Medical Device Supervision Department of the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/chongqing-hengsheng-antuo-medical-equipment-co-ltd/fb16703f-b4ef-4e63-bb46-e54862a3d097/