# China NMPA Inspection - Fangrun Medical Device Technology (Shanghai) Co., Ltd. - November 20, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/fangrun-medical-device-technology-shanghai-co-ltd/f15ad184-2e26-4d44-8742-b7c6c335d928/
Source feed: China

> China NMPA unannounced inspection for Fangrun Medical Device Technology (Shanghai) Co., Ltd. published November 20, 2017. An unannounced compliance inspection of Fangrun Medical Device Technology (Shanghai) Co., Ltd. was conducted from November 8-9, 2017, based on Good Ma

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## Details

- Record Type: CHINA_INSPECTION
- Title: Inspection Notice for Fangrun Medical Devices Technology (Shanghai) Co., Ltd.
- Company Name: Fangrun Medical Device Technology (Shanghai) Co., Ltd.
- Publication Date: 2017-11-20
- Product Type: Device
- Summary: An unannounced compliance inspection of Fangrun Medical Device Technology (Shanghai) Co., Ltd. was conducted from November 8-9, 2017, based on Good Manufacturing Practice for Medical Devices. The inspection focused on the company's existing production site and a newly proposed production facility for its Plasma Radiofrequency Therapy Instrument.

Inspectors found that the company had initiated a process to add Room 401, Building 4 as an additional production site, an application still pending administrative licensing approval from the Shanghai Municipal Food and Drug Administration. Despite the pending approval, the inspection team discovered a fully equipped production setup, corresponding personnel, and six prototype therapeutic devices at this unapproved new location, with trial production having occurred in August 2017. Conversely, the original registered production site (Room 502, Building 9) showed no active production, only raw materials, with its last manufacturing activity recorded in October 2016.

The primary issue identified was the company's engagement in production-related activities, including trial runs and establishing a production line, at a facility not yet officially approved and licensed for medical device manufacturing. This represents a significant deviation from regulatory requirements.

As a result, the Shanghai Municipal Food and Drug Administration is required to increase its oversight of Fangrun Medical Device Technology. The company has been mandated to halt all production activities at the new address until it has obtained the necessary amendments to its Medical Device Production License and Product Registration Certificate. The Shanghai Administration must also report the company's eventual resumption of production to the State Administration for Market Regulation.

Company: https://www.globalkeysolutions.net/companies/fangrun-medical-device-technology-shanghai-co-ltd/2489c073-368a-407a-83f4-24121fe6ece8/