# China NMPA Inspection - Fangrun Medical Device Technology (Shanghai) Co., Ltd. - August 01, 2018

Source: https://www.globalkeysolutions.net/records/china_inspection/fangrun-medical-device-technology-shanghai-co-ltd/b9e6a751-fbba-455b-ba8a-4ced724fc1b0/
Source feed: China

> China NMPA unannounced inspection for Fangrun Medical Device Technology (Shanghai) Co., Ltd. published August 01, 2018. An unannounced inspection of Fangrun Medical Device Technology (Shanghai) Co., Ltd. was conducted from July 12 to July 13, 2018, based on the Good Man

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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: 2018-08-01
- Product Type: Device
- Summary: An unannounced inspection of Fangrun Medical Device Technology (Shanghai) Co., Ltd. was conducted from July 12 to July 13, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection identified 12 general non-conformities related to the Plasma Radiofrequency Therapy Instrument.

Key violations included a lack of attendance records in management reviews and a production manager not meeting educational qualifications. Deficiencies in warehouse management involved absent rodent barriers and improper storage of returned products. Equipment control was found lacking, with no established operating procedures or maintenance records for production equipment, and inspection fixtures without status markings.

Significant issues in document control encompassed missing review requirements for document updates, incorrect distribution of quality management documents, discrepancies in document destruction records, and inconsistencies in material lists and supplier re-evaluation forms. Production records showed inconsistencies with procedures, incomplete environmental monitoring, and inventory inaccuracies. Additionally, software version control was inadequate, customer feedback was not analyzed, and no procedures were defined for reworkable non-conforming products.

The company is required to rectify these issues within a specified period, assess product safety risks, and potentially recall hazardous products. All rectification activities must be reported, and follow-up inspections may occur.

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