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    Home > Medical News > Medical World News > Investigation! Famous enterprise medical equipment warehouse suspected of illegal

    Investigation! Famous enterprise medical equipment warehouse suspected of illegal

    • Last Update: 2020-01-19
    • Source: Internet
    • Author: User
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    Recently, the Shanghai Municipal People's government issued the notice of Shanghai Drug Administration on the special inspection of the third-party logistics enterprises of medical devices (hereinafter referred to as the notice), which shows that the Shanghai Drug Administration organized the special inspection of some third-party logistics enterprises of medical devices in the fourth quarter After inspection, it is found that the Shanghai Branch of FedEx (China) Co., Ltd sublets the licensed medical equipment warehouse to other companies for use again, and there are illegal acts such as failing to implement the operation quality management system in accordance with the provisions The market supervision bureau of FedEx's district will further investigate the suspected violations of laws and regulations of the enterprise and deal with them in accordance with laws and regulations It is understood that FedEx Express is the largest express transportation company in the world, providing express service for more than 220 countries and regions, and has related third-party logistics services for medical devices in China In addition to FedEx, SFDA also found problems in the following third-party logistics enterprises during the inspection A medical equipment Co., Ltd misappropriated the licensed medical equipment warehouse for other purposes, stored hazardous chemicals in the warehouse and failed to store them according to the label, did not carry out the qualification and storage and transportation conditions audit of some first-time enterprises, and the quality management system had serious defects The market supervision bureau of the area where the enterprise is located will further investigate the suspected violations of laws and regulations of the enterprise, and handle them in accordance with laws and regulations A medical supply chain management Co., Ltd is ordered to make rectification within a time limit due to the inconsistency between the permitted items and the actual situation A pharmaceutical Co., Ltd and a logistics Co., Ltd Shanghai No 1 branch voluntarily submitted an application for suspension of business According to the circular, this special inspection is carried out for 20 third-party logistics enterprises that hold the Shanghai medical device business license and the business scope of the license is to provide storage and distribution services for other medical device production and operation enterprises This inspection focuses on whether the actual storage and transportation conditions of the third-party logistics enterprises are consistent with the licensing matters, whether the products are stored and transported in accordance with the requirements of the medical device product label and identification, whether the network real-time supervision information platform provided to the regulatory department is consistent with the actual situation, whether the 2018 annual self inspection report of the enterprise is true and effective, and whether the problems found in the previous year are rectified Check the actual situation In addition to the consistency of product labels and information in this inspection, the cold chain of drug delivery has been a long-term problem to be solved It is understood that according to different temperature requirements, pharmaceutical logistics warehouses are mainly divided into cold storage (2-8 ℃), cool storage (below 20 ℃) and normal temperature storage (above 30 ℃) The relevant director of the pharmaceutical logistics branch of China Federation of logistics and purchasing once showed such a group of data: in the storage area of pharmaceutical logistics in China, shady warehouse accounts for 67%, normal temperature warehouse accounts for 18%, cold storage accounts for 3% and others for 12% Among them, low temperature storage accounts for 70%, which shows the importance of cold chain to the pharmaceutical industry In addition, there are 29511 self owned medical transport vehicles in 2018, including 5030 refrigerated vehicles, accounting for about 17% Even in Shunfeng, its refrigerated vehicles only account for 4.7% of the total number of its own pharmaceutical refrigerated vehicles in China - according to the report of Shunfeng holding in the half year of 2019, there are 236 refrigerated vehicles verified by GSP.
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