# China NMPA Inspection - Covidien Medical Devices Manufacturing (Shanghai) Co., Ltd. - October 12, 2017

Source: https://www.globalkeysolutions.net/records/china_inspection/covidien-medical-devices-manufacturing-shanghai-co-ltd/15270840-c0fb-43aa-b2ca-70cb5cbbe6a2/
Source feed: China

> China NMPA unannounced inspection for Covidien Medical Devices Manufacturing (Shanghai) Co., Ltd. published October 12, 2017. Covidien Medical Devices Manufacturing (Shanghai) Co., Ltd. underwent an unannounced compliance inspection by the NMPA from September 15-16, 2017. Bas

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of unannounced inspection of Covidien Medical Devices Manufacturing (Shanghai) Co., Ltd.
- Company Name: Covidien Medical Devices Manufacturing (Shanghai) Co., Ltd.
- Publication Date: 2017-10-12
- Product Type: Device
- Summary: Covidien Medical Devices Manufacturing (Shanghai) Co., Ltd. underwent an unannounced compliance inspection by the NMPA from September 15-16, 2017. Based on the Good Manufacturing Practice for Medical Devices, the inspection uncovered several significant issues related to the company's single-channel vascular closure generator production.

Key violations included the absence of electromagnetic interference risk control measures for equipment in production and testing areas, despite the product's electromagnetic compatibility requirements. Material storage protocols were deficient, with a refrigerated item incorrectly stored in an incubator. Furthermore, the company lacked a documented basis for sampling rules used in product factory inspections and incomplete records for the design, development, conversion, and verification of product software. Critical raw materials, such as motherboards, were not subject to incoming inspection, and their design conversion and verification records were missing. Lastly, quality control and maintenance regulations or records were absent for essential testing equipment, including incandescent lamps and removable storage media, along with general handling and protection regulations for testing instruments.

The Shanghai Municipal Food and Drug Administration was instructed to order Covidien to rectify these issues within a specified timeframe, conduct follow-up inspections as needed, and require the company to assess product safety risks. Any products potentially posing safety hazards must be recalled. The SMFDA is also responsible for reporting the rectification status to the State Administration for Market Regulation's medical device supervision department.

Company: https://www.globalkeysolutions.net/companies/covidien-medical-devices-manufacturing-shanghai-co-ltd/2fdba56e-5d80-44c5-bd98-ad0577c70f2a/