Circular of the State Food and Drug Administration on the suspension and rectification of Hainan Zhongsen Biotechnology Co., Ltd. (No. 84, 2019)

Recently, the State Drug Administration organized a flight inspection of Hainan Zhongsen Biotechnology Co., Ltd The inspection found that the quality management system of the enterprise mainly had the following defects: 1 The air purification system of the enterprise in terms of equipment was shut down during the non production period, and the air purification system was not tested or verified after the production was started again If the air purification system is turned on again after shutdown, necessary test or verification shall be carried out to confirm that the requirements of specified cleanliness level can still be met II In the aspect of production management, in order to correct the loosening of the white cap after sterilization of the pipe sealer, the added process of screwing the cap after sterilization is not included in the operation instruction of the pipe sealer (zssw / sop-dgfgq-09) The enterprise has provided the confirmation report of 12000 cap lamp inspection machine, which is the equipment used in this process However, the risk of product seal damage and bacteria infection caused by the loosening of white cap after sterilization has not been analyzed and verified Enterprises that do not meet the requirements of the code shall prepare production process procedures and operation instructions to clarify the requirements of key processes and special processes No integrity test or verification was carried out before and after the use of the liquid distribution tank liquid filter and medium storage tank liquid filter in the liquid distribution filling pipeline of the conduit packer The control parameters of fss70 syringe liquid filling rubber stopper sealing machine used in filling (capping) process were not confirmed The enterprise shall confirm the special process of production and keep records, including the requirements of confirmation scheme, confirmation method, operator, result evaluation and re confirmation The quality production management system of the enterprise has serious defects and does not meet the relevant provisions of the medical device production quality management specifications The enterprise has confirmed the defects of the above quality management system
The State Food and drug administration has ordered Hainan drug administration to order the enterprise to stop production immediately for rectification according to law, and to deal seriously with those involved in violation of the regulations on the supervision and administration of medical devices and relevant laws and regulations according to law; has ordered Hainan drug administration to order the enterprise to evaluate the product safety risks, and for those that may lead to potential safety hazards according to the regulations on the supervision and administration of medical devices Recall relevant products according to the management measures The enterprise can resume production only after it has completed all project rectification and passed the reexamination of Hainan drug administration Notice is hereby given EVA's article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.