A large number of the most professional inspectors are coming

▍ finishing: Chocolate On November 13, the State Food and Drug Administration issued two successive flight inspection notices, and two machinery enterprises in Shanghai and Taizhou, Zhejiang, stopped production for rectification According to the notice, there are defects in the factory building and facilities, non conformity control, and adverse event detection, analysis and improvement of an equipment enterprise in Shanghai In terms of workshop and facilities, it was found that there were powder like debris in the cabinet under the pool in the clean workshop of the enterprise, obvious dust on the floor of the sanitary ware room, and obvious pollutants such as dirt and hair on the sanitary ware (mop, broom, etc.), which did not conform to the relevant provisions of the code for quality management of medical equipment production (hereinafter referred to as the code) In Taizhou, Zhejiang Province, there are some defects in the organization personnel, plant facilities, design and development, as well as the control of unqualified products In terms of institutional personnel, the enterprise failed to provide the inspector training and examination records responsible for the process inspection of certain equipment in the clean production workshop; in terms of plant implementation, it was found that there was no humidity regulating device in the warehouse; there was water under one side of the wall in the enterprise's finished product warehouse, and the outer packing box of finished products close to the side wall was wet, etc In addition to the above-mentioned two machinery enterprises, on November 7 and November 12, the State Food and drug administration respectively issued a circular saying that the quality management system of Hangzhou and Suzhou machinery enterprises had defects after the flight inspection, and they stopped production for rectification In less than a week, the State Food and Drug Administration issued four notices on the suspension of aerial inspection of machinery enterprises Not only the State Food and drug administration, but also the Shanghai food and Drug Administration issued the notice of the Shanghai Drug Administration on the flight inspection of medical device production and operation enterprises on November 12 According to the statistics of cypress blue equipment, including Beckman Kurt Trading (China) Co., Ltd., there are 14 machinery enterprises that have been shut down, further investigated or transferred to relevant departments for treatment Among them, there are 7 medical device management enterprises and 7 medical device production enterprises It is worth noting that according to the information from Shanghai drug regulatory bureau, the flight inspection is also combined with inspector training In this flight inspection, 43 inspectors were randomly selected from the equipment supervision department of SFDA, the certification and evaluation center, the law enforcement team of SFDA and the market supervision bureau of each district Inspectors conduct flight inspection on some high-risk medical device manufacturers listed in the five-level supervision and high-risk medical device business enterprises selling sterile implants or products with special temperature control requirements Focus on checking the effective operation of the quality management system of the enterprise, the performance of the management representative, the annual self inspection report of the enterprise, the monitoring report of adverse events, etc In fact, it is not only Shanghai that is promoting the cultivation of inspectors, but inspectors across the country may become more and more professional and strict in flight inspection On July 18 this year, the general office of the State Council issued the opinions on establishing a team of professional and professional drug inspectors, and clearly pointed out that the state will adhere to strict prevention at the source, strict management in the process and strict risk control, strengthen safety supervision and inspection, and effectively guarantee the safety of people's use of equipment At the same time, it is emphasized that the professional medical device inspector refers to the personnel who have been identified by the drug regulatory authorities to confirm the compliance and conduct risk study and judgment on the places and activities where the management counterpart is engaged in drug development and production according to law, which is an important support for strengthening supervision and ensuring safety.