# China NMPA Inspection - Gansu Chenxu Medical Technology Co., Ltd. - July 07, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/gansu-chenxu-medical-technology-co-ltd/1b76ab1c-2517-47ce-a12a-3c5e1ad13af3/
Source feed: China

> China NMPA unannounced inspection for Gansu Chenxu Medical Technology Co., Ltd. published July 07, 2017. An unannounced inspection conducted by the State Food and Drug Administration (SFDA) on June 9, 2017, targeted Gansu Chenxu Medical Technology Co., Lt

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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 Gansu Chenxu Medical Technology Co., Ltd. to Conduct Follow-up Inspections of Issues Discovered During Flight Inspections
- Company Name: Gansu Chenxu Medical Technology Co., Ltd.
- Publication Date: 2017-07-07
- Product Type: Device
- Summary: An unannounced inspection conducted by the State Food and Drug Administration (SFDA) on June 9, 2017, targeted Gansu Chenxu Medical Technology Co., Ltd., a manufacturer of disposable retractable self-destructing insulin injectors. The inspection, carried out under the "Regulations on Unannounced Inspections of Drugs and Medical Devices" and aiming to assess compliance with Good Manufacturing Practice (GMP) for Medical Devices and its sterile devices appendix, found that the company had ceased production since January 2013 and its workshop was not in operation. The company had previously reported its production stoppage to provincial and municipal authorities.

To resume operations, Gansu Chenxu Medical Technology Co., Ltd. must submit a comprehensive written report to the Gansu Provincial Food and Drug Administration. Production can only recommence after the Gansu Provincial Food and Drug Administration conducts a thorough verification and confirms that all regulatory requirements are satisfied. Furthermore, the Gansu Provincial Food and Drug Administration is tasked with promptly reporting the company's resumption of production to the national Medical Device Supervision Department of the SFDA, ensuring proper oversight as the company addresses its inactive status.

Company: https://www.globalkeysolutions.net/companies/gansu-chenxu-medical-technology-co-ltd/6435f9e0-58c4-49e2-ab76-985e05449854/