On February 14, the State Food and Drug Administration issued the "Notice on the Inspection Results of 13 Medical Device Business Enterprises, such as Yishan Biotechnology Co., Ltd." (No. 22, 2017, hereinafter referred to as the "Notice"), announced to the public Flight inspection results.
According to the Notice, the on-site inspection found that Yishan Biotechnology Co., Ltd., Guangdong Hexin Biotechnology Co., Ltd., Beijing Hantong Ruicheng Medical Devices Co., Ltd., Heilongjiang Renze Medical Devices Co., Ltd., China Resources Jilin Cornell Pharmaceutical Co., Ltd. The company, Jiangsu Keyu Medical Devices Trading Co., Ltd., Jiangsu Tide Pharmaceutical Co., Ltd., Guizhou Bijie Senyue Medical Devices Co., Ltd. and other 8 medical device operating companies have "Announcement on Remediation of Illegal Business Activities in the Field of Medical Device Distribution" (2016 The illegal business practices mentioned in No. 112) violate the relevant regulations of the Medical Device Supervision and Administration Regulations (hereinafter referred to as the “Regulationsâ€), “Measures for the Supervision and Administration of Medical Device Managementâ€.
In accordance with the relevant provisions of the "Regulations", the State Food and Drug Administration has requested the relevant provincial food and drug administration to file an investigation into the illegal business operations of the above-mentioned enterprises, and deal with them seriously according to law. If the circumstances are serious, the business shall be ordered to suspend business until the Medical Device Business License is revoked. Constitute a crime, be held criminally responsible. The State Food and Drug Administration will supervise the above-mentioned illegal business cases.
The "Notice" shows that the on-site inspection found that Sinopharm Group (Tianjin) Medical Devices Co., Ltd., Tianjin Kaiwen Hengtai Technology Development Co., Ltd., BD Medical Devices (Shanghai) Co., Ltd., Roche Diagnostics Products (Shanghai) Co., Ltd., Hunan Kehengkang Medical Technology Co., Ltd. The above five medical device operators have problems that do not meet the requirements of the "Quality Management Standards for Medical Device Management". The State Food and Drug Administration has requested the relevant provincial food and drug administration to order the above enterprises to rectify within a time limit. And supervise the company's actual rectification in place.
The State Food and Drug Administration requires all provinces (autonomous regions and municipalities) to implement regulatory responsibilities, organize and investigate potential risks in the circulation of medical devices, and improve the pertinence, targeting and effectiveness of inspections. Further strengthen supervision and inspection of medical device circulation, grasp supervision and implementation, promote implementation, continue to maintain high-pressure situation, severely investigate and deal with illegal business practices, and effectively guarantee the quality and safety of medical device products.
Notice of the Directorate of the inspection results of 13 medical device companies such as Yishan Biotechnology Co., Ltd. (No. 22, 2017)
On-site inspection found that 8 medical device operating companies such as Yishan Biotechnology Co., Ltd. had illegal business operations as described in the Announcement, as follows:
Yishan Biotechnology Co., Ltd.
The content of the inspection records of Yishan Biotechnology Co., Ltd. is incomplete, lacking the product registration certificate number and the number of qualified acceptances. The enterprise purchase acceptance record is incomplete, lacking the product registration certificate number and the acceptance quantity. The enterprise sales management regulations (document number: MD-SOP-MS-003) do not specify the period of validity of the sales records of medical devices without valid period (not less than 5 years). The company is suspected of operating a medical device that has not obtained a medical device registration certificate. The product is inspected on the spot (No.: YSSWXOUT000556). Its manufacturer: Yishan Biotechnology Co., Ltd., probe protection solution A (batch number), probe protection solution B (batch number), probe protection liquid C (batch number), the company cannot provide product registration certificate. Multi-function flow dot matrix instrument (National Food and Drug Administration (into) word 2013 No. 3404548), upright microscope (registration number: National Food and Drug Administration (in) word 2014 No. 2221528), microscopic image Imported medical devices such as the automatic scanning and analysis software Metafer (Registration No.: National Machinery Injection 20152700888) and Fluorescence In Situ Hybridization Analysis Software Isis (Registration No.: National Machinery Injection 20152700887) failed to provide the certification documents. Purchasing medical devices did not strictly review the legality of supplier qualifications, and purchased the second type of medical device microscopic image automatic scanning and analysis software Metafer (Registration No.: National Machinery Injection 20152700888) and fluorescence in situ hybridization analysis software Isis ( Registration Certificate No.: National Machinery Note 20152700887) The supplier of the product Jianfa (Guangzhou) Co., Ltd. does not have the qualification of Class II 6870 software. The company did not report the 2015 self-inspection report to the Guangzhou Food and Drug Administration. The company's business scope includes in vitro diagnostic reagents for storage at room temperature, but is not equipped with competent inspectors or laboratory related professionals. The storage area of ​​the packaging material is not set in the enterprise warehouse. The management of the enterprise warehouse is chaotic, and the equipment needed for the production of the gene amplification instrument, centrifuge, vacuum pump, etc. is stored in the warehouse (the enterprise has the "Medical Device Production License").
Nosiheptide Feed Additives,Nosiheptide Antibiotics,Nosiheptide Growth Prompter,Nosiheptide Poultry
Shandong Shengli Bioengineering Co., Ltd , https://www.shenglipharm.com